Goparib^TM100

Olaparib Tablets 100 mg 

PRESENTATION: Each film-coated tablet contains:
Olaparib………………….100 mg
Excipients……………………… q.s.

Colors: Black Oxide of Iron, Yellow Oxide of Iron, and Titanium Dioxide I.P.  

Goparib^TM150

Olaparib Tablets 150 mg  

PRESENTATION: Each film-coated tablet contains:
Olaparib………………….150 mg
Excipients……………………… q.s.

Colors: Black Oxide of Iron, Yellow Oxide of Iron, and Titanium Dioxide I.P.  

PHARMACEUTICAL FORM: Film Coated Tablets for Oral Use Only.

INDICATIONS Ovarian cancer: • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. • Olaparib in combination with bevacizumab is indicated for the Maintenance treatment of adult patients with advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (Complete response or partial response) to first-line platinum-based chemotherapy with bevacizumab. Breast Cancer: • In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Pancreatic Cancer: • Olaparib is indicated as monotherapy for the Maintenance treatment of adult patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy. Prostate Cancer: • Olaparib is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.

DOSAGE AND ADMINISTRATION: The recommended dose of Olaparib Tablets is 300 mg (two 150 mg tablets) taken orally twice daily, with or without food, for a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Swallow tablets whole. Do not chew, crush, dissolve, or divide the tablet.

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients used in the formulation.

WARNINGS & PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia Overall, the incidence of Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) in patients treated with Olaparib Tablets monotherapy in clinical trials, including long-term follow-up, was < 6 months to > 2 years. Pneumonitis Pneumonitis, including fatal cases, occurred in <1% of patients treated with Olaparib Tablets. Embryo-Fetal Toxicity Olaparib Tablets can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals.

DRUG INTERACTIONS: Anticancer Agents Clinical studies of Olaparib tablet in combination with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. Drugs That May Increase Olaparib Plasma Concentrations Avoid concomitant use of strong CYP3A inhibitors and moderate CYPA inhibitors. Drugs That May Decrease Olaparib Plasma Concentrations Avoid concomitant use of strong CYP3A inducers and moderate CYP3A4 inducers.

PREGNANCY & LACTATION: Pregnancy Based on findings in animals and its mechanism of action, Olaparib Tablets can cause fetal harm when administered to a pregnant woman. Lactation Because of the potential for serious adverse reactions in the breastfed infants from Olaparib Tablets, advise a lactating woman not to breastfeed during treatment with Olaparib Tablets and for one month after receiving the last dose.

SYMPTOMS AND TREATMENT OF OVERDOSAGE There is no specific treatment in the event of Olaparib overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically.

STORAGE: Store below 30°C. Keep out of sight and reach of children.

PACK SIZE: 30 tablets are supplied in bottles.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

PRESENTATION: Each film-coated tablet contains:
Relugolix ……120 mg
Excipients……….………q.s.

Colours: Iron oxide red NF, Titanium dioxide USP

PHARMACEUTICAL FORM Film Coated Tablet

INDICATIONS Relugolix Tablets 120 mg is indicated for the treatment of adult patients with advanced prostate cancer.

DOSAGE AND ADMINISTRATION Treatment with Relugolix Tablets 120 mg should be initiated with a loading dose of 360 mg (three Tablets) on the first day, followed by a 120 mg (one tablet) dose taken once daily at approximately the same time each day.

Method of administration: For oral administration only.

CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients used in formulation.

WARNINGS & PRECAUTIONS Effect on QT/QTc interval prolongation: Androgen deprivation therapy may prolong the QT interval. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating Relugolix Tablets 120 mg.

DRUG INTERACTION P-gp inhibitors: Co-administration of Relugolix Tablets 120 mg and oral P-gp inhibitors should be avoided. Combined P-gp and strong CYP3A inducers: Co-administration of Relugolix Tablets 120 mg with combined P-gp and strong CYP3A inducers should be avoided.

PREGNANCY & LACTATION Pregnancy: There is a limited amount of data from the use of relugolix in pregnant women. Studies in animals have shown that exposure to relugolix in early pregnancy may increase the risk of early pregnancy loss. Breastfeeding: No data are available regarding the presence of Relugolix or its metabolites in human milk or its effect on the breast-fed infant.

SYMPTOMS AND TREATMENT OF OVERDOSAGE There is no known specific antidote for overdose with Relugolix Tablets 120 mg. In the event of an overdose, Relugolix Tablets 120 mg should be stopped, and general supportive measures should be undertaken until any clinical toxicity has diminished or resolved, taking into consideration the half-life of 61.5 hours.

STORAGE Store below 30°C. Keep out of reach of children.

PACK SIZE: 30 tablets are supplied in bottles.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

ENZANEAL^TM40

Enzalutamide Capsules 40 mg 

PRESENTATION: Each hard gelatin capsule contains:
Enzalutamide…………..40 mg
Excipients……………….q.s.

Approved colours used in empty capsule shell.

PHARMACEUTICAL FORM: Hard Gelatin Capsules

INDICATIONS: For the treatment adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after Docetaxel therapy.

DOSAGE AND ADMINISTRATION: The recommended dose is 160 mg of enzalutamide (two 40 mg capsules) as a single oral daily dose.  

Method of administration: For oral administration only. The capsules should be swallowed whole without opening and are not to be chewed or dissolved or opened.

CONTRAINDICATIONS • Individual hypersensitivity to the active substance or excipients of the product. • Enzalutamide is not indicated for use by women who are or may become pregnant.

WARNINGS & PRECAUTIONS Seizure Risk: Enzalutamide, an antiandrogen, carries a risk of seizures. Cardiovascular Risk: New hormonal agents for mCRPC treatment may increase cardiovascular toxicity. QT Interval Prolongation: Androgen deprivation therapy, including enzalutamide, may prolong QT intervals. Hypersensitivity Reactions: Hypersensitivity reactions, including tongue, lip, and pharyngeal edema, have been reported. Physicians should be vigilant for such manifestations.

DRUG INTERACTION CYP2C8 Inhibitors: Avoid if possible; if necessary, reduce enzalutamide dose to 40 mg daily.

PREGNANCY & LACTATION Pregnancy: Enzalutamide is contraindicated in pregnant women due to potential fatal harm. Breast-Feeding: Not recommended in women; no evidence of harm in humans, but caution based on rat studies.

SYMPTOMS AND TREATMENT OF OVERDOSAGE: There is no antidote for enzalutamide.

STORAGE: Store below 30°C. Protect from light and moisture. Keep all medicine out of reach & sight of children.

PACK SIZE: Aluminium PVC Blister of 28 Capsules with pack insert.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

ENZANEAL^TM160

Enzalutamide Tablets 160 mg  

PRESENTATION: Each film-coated tablet contains:
Enzalutamide………………….160 mg
Excipients……………………… q.s.

Colors: Red Oxide of Iron, Yellow Oxide of Iron & Titanium Dioxide I.P.

PHARMACEUTICAL FORM: Film coated tablet.

INDICATIONS Enzalutamide is indicated for •Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. •The treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC). •The treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. •The treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

DOSAGE AND ADMINISTRATION: The recommended dose is 160 mg as a single oral daily dose. Medical castration with an LHRH analogue should continue for non-surgically castrated patients.

CONTRAINDICATIONS: Hypersensitivity to the active substance or any excipients, Women who are or may become pregnant.

WARNINGS & PRECAUTIONS Seizure Risk: Use of enzalutamide is associated with seizures; decisions to continue treatment in such cases should be individualized. Posterior Reversible Encephalopathy Syndrome (PRES): Diagnosis requires brain imaging; enzalutamide discontinuation is recommended for patients developing PRES. Second Primary Malignancies: Patients should promptly report signs of gastrointestinal bleeding, haematuria, or other symptoms during treatment.

DRUG INTERACTIONS: Other Medicinal Products Affecting Enzalutamide: CYP2C8 inhibitors may require dose reduction; caution with P-gp substrates and QT-prolonging drugs,

PREGNANCY & LACTATION: Contraindicated in pregnant women, Not recommended for women; potential harm to the unborn child.

SYMPTOMS AND TREATMENT OF OVERDOSAGE No specific antidote; discontinue treatment and initiate supportive measures, Increased seizure risk in overdose; consider patient monitoring.

STORAGE: Store below 30°C

PACK SIZE: Blister pack of 7 Tablets  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

ABIRANEAL^TM-250

Abiraterone Acetate Tablets I.P. 250 mg 

PRESENTATION: Each uncoated tablet contains:
Abiraterone Acetate I.P. ……………. 250 mg
Excipients ……………………….. q.s.  

ABIRANEAL^TM-500

Abiraterone Acetate Tablets I.P. 500 mg  

PRESENTATION: Each film-coated tablet contains:
Abiraterone Acetate I.P. …………………….. 500 mg
Excipients ………………………….. q.s.

Colour: Titanium Dioxide I.P.  

PHARMACEUTICAL FORM: Tablets

INDICATIONS: Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) & for the treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

DOSAGE AND ADMINISTRATION: The recommended dose is 1,000 mg (two 500 mg tablets) as a single daily dose that must not be taken with food. For mCRPC, abiraterone is used with 10 mg prednisone or prednisolone daily.

Method of administration: For oral administration only.

CONTRAINDICATIONS: • Hypersensitivity to the active substance or to any of the excipients • Women who are or may potentially be pregnant. • Severe hepatic impairment [Child-Pugh Class C] • Abiraterone with prednisone or prednisolone is contraindicated in combination with Ra-223.

WARNINGS & PRECAUTIONS: Abiraterone may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Abiraterone should be used with caution in patients with a history of cardiovascular disease. Anaemia, decreased bone density, and sexual dysfunction may occur in men with metastatic prostate cancer.

DRUG INTERACTION: Administration with food significantly increases the absorption of abiraterone acetate therefore the product must not be taken with food. Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John’s wort [Hypericum perforatum]) during treatment are to be avoided. Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels hence use with Abiraterone is not recommended.

PREGNANCY & LACTATION Pregnancy: Abiraterone is not for use in women and is contraindicated in women who are or may potentially be pregnant. Breastfeeding: Abiraterone is not for use in women. It is not known if abiraterone acetate is excreted in human milk.

SYMPTOMS AND TREATMENT OF OVERDOSAGE: Human experience of overdose with abiraterone is limited. There is no specific antidote. In the event of an overdose, administration should be withheld, and general supportive measures undertaken.

STORAGE: Store protected from light and moisture, at a temperature not exceeding 30°C. Keep out of reach of children.

PACK SIZE ABIRANEAL-250 – HDPE container pack of 120 tablets. ABIRANEAL-500 – HDPE container pack of 60 tablets. Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

TRASTUNEAL^TM-150

Trastuzumab for Injection 150 mg Lyophilized Powder for Concentrate for Solution for Intravenous Infusion  

PRESENTATION: Each Trastuneal-150 Combipack contains:
Vial-1: Trastuzumab for Injection 150 mg
Each vial contains: Trastuzumab (r-DNA origin) IH 150 mg, α,α -Trehalose dihydrate USP 136.2 mg, L-Histidine HCl Monohydrate EP 3.36 mg, L-Histidine USP 2.16 mg, Polysorbate 20 I.P 0.6 mg. Vial-2: Bacteriostatic Water For Injection 10ml (Diluent) Each ml contains: Benzyl Alcohol I.P 1.1% v/v, Water for Injections I.P q.s.  

TRASTUNEAL^TM-440

Trastuzumab for Injection 440 mg Lyophilized Powder for Concentrate for Solution for Intravenous Infusion  

PRESENTATION: Each Trastuneal-440 Combipack contains:
Vial-1: Trastuzumab for Injection 440 mg Each vial contains: Trastuzumab (r-DNA origin) IH 440 mg, α,α -Trehalose dihydrate USP 400 mg, L-Histidine HCl Monohydrate EP 9.9 mg, L-Histidine USP 6.4 mg, Polysorbate 20 I.P 1.8 mg. Vial-2: Bacteriostatic Water For Injection 20ml (Diluent) Each ml contains: Benzyl Alcohol I.P 1.1% v/v, Water for Injections I.P q.s.  

PHARMACEUTICAL FORM: Lyophilized Powder for concentrate for solution for Intravenous infusion.

INDICATIONS: For the treatment of patients with HER2-positive breast cancer.

DOSAGE AND ADMINISTRATION: Metastatic breast cancer: Three-weekly schedule: The recommended initial loading dose is 8 mg/kg body weight & maintenance is 6 mg/kg body weight, beginning three weeks after the loading dose. Weekly schedule: The recommended initial loading dose is 4 mg/kg body weight & maintenance dose of is 2 mg/kg body weight, beginning one week after the loading dose. Early breast cancer: Three-weekly and weekly schedule: The recommended initial loading dose is 8 mg/kg body weight & maintenance dose is 6 mg/kg body weight, beginning three weeks after the loading dose.

CONTRAINDICATIONS: • Hypersensitivity to trastuzumab, murine proteins or to any of the other excipients. • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

WARNINGS & PRECAUTIONS: Patients treated with Trastuzumab are at increased risk for developing CHF or asymptomatic cardiac dysfunction.

DRUG INTERACTION: Clinically significant interactions between Trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.

PREGNANCY & LACTATION: Pregnancy: Women who become pregnant should be advised of the possibility of harm to the fetus. Breastfeeding: It is not known whether trastuzumab is secreted in human milk.

SYMPTOMS AND TREATMENT OF OVERDOSAGE: There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg have not been tested.

STORAGE: Store between 2°C to 8°C.

PACK SIZE: Container closure of Trastuzumab Lyophilized powder for Injection: Glass vials (USP type-I glass) with rubber stopper and flip-off seals.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

Capecitabine Tablets I.P. 500 mg  

PRESENTATION: Each film-coated tablet contains:
Capecitabine I.P……………………500 mg
Excipients…………………………..q.s.

Colours: Ferric oxide USP-NF Red & Titanium Dioxide I.P.

PHARMACEUTICAL FORM Film Coated Tablet

INDICATIONS Capecitabine is indicated for the treatment of (i) First line treatment of advanced gastric cancer in combination with a platinum-based regimen. (ii) Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy. (iii) First line treatment in patients with metastatic colorectal carcinoma. (iv) For the treatment of patients with metastatic colorectal cancer. (v) For the treatment of metastatic breast cancer after failure of paclitaxel and an anthracycline-containing chemotherapy regimen.

DOSAGE AND ADMINISTRATION Metastatic Colorectal Cancer Single Agent The recommended dosage of Capecitabine is 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity. Recommended Dosage for Breast Cancer Advanced or Metastatic Breast Cancer Single Agent The recommended dosage of Capecitabine is 1,000 mg/m2 or 1,250 mg/m2 orally twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity.

Method of administration: For oral administration only.

CONTRAINDICATIONS Capecitabine is contraindicated in patients with a history of severe hypersensitivity reaction to fluorouracil or capecitabine.

WARNINGS & PRECAUTIONS Capecitabine is not recommended for use in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD (Dihydropyrimidine Dehydrogenase) deficiency.

DRUG INTERACTION Effect of Other Drugs on Capecitabine Allopurinol Concomitant use with allopurinol may decrease the concentration of capecitabine’s active metabolites, which may decrease efficacy. Avoid concomitant use of allopurinol with Capecitabine. Effect of Capecitabine on Other Drugs Vitamin K Antagonists Capecitabine increases exposure to vitamin K antagonist, which may alter coagulation parameters and/or bleeding and could result in death.

PREGNANCY & LACTATION Pregnancy Based on findings in animal reproduction studies and its mechanism of action, Capecitabine can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Breastfeeding There is no information regarding the presence of capecitabine or its metabolites in human milk, or on its effects on milk production or the breastfed child.

SYMPTOMS AND TREATMENT OF OVERDOSAGE Administer uridine triacetate within 96 hours for the management of Capecitabine overdose. Although no clinical experience using dialysis as a treatment for Capecitabine overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5’-DFUR.

STORAGE Store at a temperature not exceeding 30°C. Keep out of reach of children.

PACK SIZE: Blister Pack of 10 Tablets.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.

To be sold by retail on the prescription of an Oncologist only. 

Paclitaxel (Protein Bound particles) for Injectable Suspension 100 mg/vial  

PRESENTATION: Each vial contains:
Paclitaxel I.P……………….100 mg
Human Albumin I.P. Approximately……………..900 mg (After reconstitution)

PHARMACEUTICAL FORM: Lyophilized powder for suspension for infusion.

INDICATIONS 1. For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 2. For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. 3. As first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, it is indicated in combination with cisplatin. 4. In combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. 5. For the second-line treatment of AIDS-related Kaposi’s sarcoma. 6. Management of endometriosis associated pain. 7. For the treatment of advanced gastric carcinoma. Advanced squamous cell carcinoma of Head and Neck SCCHN: 8. Diagnosed but unresectable locally advanced SCCHN 9. Recurrent SCCHN, if surgery or radiation is not feasible. 10. Palliative treatment of metastatic SCCHN.

DOSAGE AND ADMINISTRATION • Metastatic Breast Cancer: 260 mg/m2 intravenously over 30 minutes every 3 weeks. Dosage Adjustments: • Hepatic Impairment: Adjust doses based on individual tolerance, ranging from 130 mg/ m2 to 200 mg/ m2 for breast cancer and 50 mg/ m2 to 75 mg/ m2 for NSCLC.

CONTRAINDICATIONS • Severe hypersensitivity reaction to Paclitaxel.

WARNINGS & PRECAUTIONS • Monitor myelotoxicity; do not administer to patients with baseline ANC <1,500 cells/mm3. • Sensory neuropathy is dose-dependent; manage Grade 3 neuropathy with dose modifications. • Adjust starting dose for hepatic impairment & Monitor for injection site reactions.

DRUG INTERACTION • Caution with medicines inhibiting or inducing CYP2C8 or CYP3A4; no formal clinical drug interaction studies conducted.  

PREGNANCY & LACTATION • Pregnancy: Can cause fetal harm; avoid during pregnancy. • Nursing Mothers: Decision to discontinue nursing or drug should be made, considering potential adverse reactions in infants.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE • No known antidote: complications may include bone marrow suppression, sensory neurotoxicity, and mucositis.  

STORAGE: Store vial in its original carton at controlled room temperature between 20°C and 25°C. Reconstituted suspension should be stored in the original carton at 2°C to 8°C. Protect from bright light.  

PACK SIZE: 50 ml USP type I tubular glass vial (single use)  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only. 

CABONEAL^TM20

Cabozantinib Tablets 20 mg 

PRESENTATION: Each film-coated tablet contains:  
Cabozantinib S-Malate Eq. to Cabozantinib …… 20 mg  
Excipients………… q.s.  

Colour: Red Oxide of Iron  

CABONEAL^TM40

Cabozantinib Tablets 40 mg  

PRESENTATION: Each film-coated tablet contains:  
Cabozantinib S-Malate Eq. to Cabozantinib …… 40 mg  
Excipients………… q.s.  

Colour: Red Oxide of Iron  

PHARMACEUTICAL FORM: Film Coated Tablet  

INDICATIONS (1) For the treatment of patients with advanced renal cell carcinoma (RCC). (2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib.  

DOSAGE AND ADMINISTRATION The recommended dose of Cabozantinib is 40 mg once daily in combination with nivolumab administered intravenously at either 240 mg every 2 weeks or 480 mg every 4 weeks.  

Method of administration: For oral administration only.  

CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients used in formulation.  

WARNINGS & PRECAUTIONS As most adverse reactions occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted. Adverse reactions that generally have early onset include hypocalcaemia, hypokalaemia, thrombocytopenia, hypertension, palmar-plantar erythrodysaesthesia syndrome (PPES), proteinuria, and gastrointestinal (GI) events (abdominal pain, mucosal inflammation, constipation, diarrhoea, vomiting). Management of suspected adverse reactions may require temporary interruption or dose reduction of cabozantinib therapy.  

DRUG INTERACTION Effect of other medicinal products on cabozantinib CYP3A4 inhibitors and inducers, Gastric pH modifying agents, MRP2 inhibitors, Bile salt-sequestering agents  

PREGNANCY & LACTATION Pregnancy There are no studies in pregnant women using cabozantinib. Studies in animals have shown embryo-foetal and teratogenic effects. The potential risk for humans is unknown. Breastfeeding It is not known whether cabozantinib and/or its metabolites are excreted in human milk.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established. STORAGE Store at a temperature not exceeding 30°C, protect from moisture.  

PACK SIZE: 30 tablets are supplied in bottles.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only. 

LENVANEAL^TM-4

Lenvatinib Capsules I.P. 4 mg  

PRESENTATION: Each hard capsule contains:  
Lenvatinib mesylate I.P. ………….. 4.90 mg Eq. to Lenvatinib ……………………. 4 mg  
Excipients …………………………….. q.s.  

Approved colours are used in capsule shells.  

LENVANEAL^TM-10

Lenvatinib Capsules I.P. 10 mg  

PRESENTATION: Each hard capsule contains:  
Lenvatinib mesylate I.P. ………….. 12.25 mg Eq. to Lenvatinib ……………………. 10 mg  
Excipients …………………………….. q.s.  

Approved colours are used in capsule shells.  

PHARMACEUTICAL FORM Hard capsule  

INDICATIONS Lenvatinib capsule is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer. In addition, it is also approved for use in the treatment of advanced renal cell carcinoma (RCC) in combination with everolimus and also for the first-line treatment of patients with unresectable hepatocellular carcinoma.  

DOSAGE AND ADMINISTRATION The recommended daily dose of Lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily.  

Method of administration: Lenvatinib is for oral use.  

CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients of this product.  

WARNINGS & PRECAUTIONS Aneurysms and artery dissections: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.  

DRUG INTERACTION Effect of Lenvatinib on other medicinal products: A clinical drug-drug interaction (DDI) study in cancer patients showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of Lenvatinib.  

PREGNANCY & LACTATION Pregnancy: There are no data on the use of Lenvatinib in pregnant women. Breastfeeding: It is not known whether Lenvatinib is excreted in human milk.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE. Overdose with Lenvatinib involving single administrations of 6 to 10 times the recommended daily dose. There is no specific antidote for overdose with Lenvatinib. In case of suspected overdose.  

STORAGE Store at a temperature not exceeding 30°C. Protect from light and moisture. Keep out of the reach of children.  

PACK SIZE: 10 Capsules packed in a blister, such 3 blisters packed in a carton along with a pack insert.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only. 

AXINEAL^TM-1

Axitinib Tablets 1 mg  

PRESENTATION: Each film-coated tablet contains:  
Axitinib ………. 5 mg
Excipients ………….. q.s.

Colors: Ferric oxide USP-NF Red and Titanium dioxide I.P.  

AXINEAL^TM-5

Axitinib Tablets 5 mg  

PRESENTATION: Each film-coated tablet contains:  
Axitinib ………. 5 mg
Excipients ………….. q.s.

Colors: Ferric oxide USP-NF Red and Titanium dioxide I.P.  

PHARMACEUTICAL FORM: Tablets  

INDICATIONS: Axitinib is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.  

DOSAGE AND ADMINISTRATION: The recommended dose of axitinib is 5 mg twice daily.  

Method of administration: For oral administration only.  

CONTRAINDICATIONS: Hypersensitivity to axitinib  

WARNINGS & PRECAUTIONS: In clinical studies with axitinib, cardiac failure, hypertension, hypothyroidism, arterial embolic, venous embolic, haemorrhagic, gastrointestinal perforation, fistulas, proteinuria, thrombotic and Posterior reversible encephalopathy syndrome events were reported. Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.  

DRUG INTERACTION: In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1. CYP3A4/5 inhibitors: Ketoconazole, a strong inhibitor of CYP3A4/5. Co-administration of axitinib with strong CYP3A4/5 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) may increase axitinib plasma concentrations. CYP3A4/5 inducers: Rifampicin, a strong inducer of CYP3A4/5. Co-administration of axitinib with strong CYP3A4/5 inducers (e.g., rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and Hypericum perforatum [St. John’s wort]) may decrease axitinib plasma concentrations.  

PREGNANCY & LACTATION: Pregnancy: There are no data regarding the use of axitinib in pregnant women. Breastfeeding: It is unknown whether axitinib is excreted in human milk. A risk to the suckling child cannot be excluded. Axitinib should not be used during breastfeeding.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE: There is no specific treatment for axitinib overdose. In cases of suspected overdose, axitinib should be withheld and supportive care instituted.  

STORAGE: Store at a temperature not exceeding 30°C. Protect from light. Keep out of the reach of children. 

 PACK SIZE: 14 tablets per strip and one strip in carton with package leaflet.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only. 

PRESENTATION: Each ml contains:  
Ferric Carboxymaltose equivalent to Elemental Iron 50 mg, Water for Injection I.P. q.s.  

PHARMACEUTICAL FORM: Injections  

INDICATIONS: Ferric carboxymaltose Injection is indicated for the treatment of iron deficiency anemia (IDA) in Adults and pediatric patients.  

DOSAGE AND ADMINISTRATION: Recommended Dosage: For patients weighing 50 kg or more, the recommended dosage is Ferric carboxymaltose Injection 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. Preparation and Administration: Administer Ferric carboxymaltose Injection intravenously, either as an undiluted slow intravenous push or by infusion. Each vial of Ferric carboxymaltose Injection is intended for single dose only.  

CONTRAINDICATIONS: Ferric carboxymaltose Injection is contraindicated in patients with a history of hypersensitivity to Ferric carboxymaltose Injection or any of its components.  

WARNINGS & PRECAUTIONS: Serious hypersensitivity reactions, including anaphylactic-type reactions have been reported. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse.  

PREGNANCY & LACTATION: Pregnancy: Parenteral iron administration may be associated with hypersensitivity reactions which may have serious consequences, such as fetal bradycardia. Breastfeeding: The available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE: Excessive dosages of ferric carboxymaltose injection may lead to accumulation of iron in storage sites potentially leading to hemosiderosis.  

STORAGE: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.  

PACK SIZE: One vial of 20 mL in plastic tray packed in mono carton.  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only. 

PRESENTATION: Romiplostim 250 micrograms Lyophilized powder for solution for Injection. Each vial contains 250 mcg of romiplostim.  

List of excipients: Mannitol, Sucrose, L-Histidine, Hydrochloric Acid (For pH adjustment), Polysorbate 20  

PHARMACEUTICAL FORM: Lyophilized powder for solution for injection  

INDICATIONS: For chronic immune thrombocytopenic purpura (ITP) patients one year of age and older who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.  

DOSAGE AND ADMINISTRATION Posology: Administered once weekly as a subcutaneous injection. Initial Dose: 1 mcg/kg based on actual body weight. Treatment Discontinuation: Discontinue if platelet count doesn’t increase sufficiently after four weeks at the highest weekly dose of 10 mcg/kg.  

Method of Administration: Subcutaneous use.  

CONTRAINDICATIONS Hypersensitivity to the active substance or any excipients.  

WARNINGS & PRECAUTIONS: Reoccurrence of Thrombocytopenia and Bleeding, Increased Bone Marrow Reticulin, Thrombotic/Thromboembolic Complications, Progression of Myelodysplastic Syndromes  

DRUG INTERACTION No interaction studies conducted, monitor platelet counts when combining with other medicinal products for the treatment of ITP to avoid counts outside the recommended range.  

PREGNANCY & LACTATION Pregnant Women: Not recommended during pregnancy or in women of childbearing potential not using contraception. Lactating Women: Unknown excretion in human milk; potential risk to newborns/infants. Decision to discontinue breastfeeding or romiplostim therapy should consider benefits for the child and the woman.  

SYMPTOMS AND TREATMENT OF OVERDOSAGE No adverse effects seen at high doses in animal studies. In the event of overdose, monitor platelet counts; discontinue and reinitiate treatment in accordance with dosing recommendations if excessively increased platelet counts lead to thrombotic complications.  

STORAGE: Store in a refrigerator (2°C – 8°C), Do not freeze. 

PACK SIZE: 5 ml single-dose vial (type 1 clear glass)  

Before prescribing, please consult full prescribing information available from Amneal Healthcare Private Limited (Formerly known as Amneal Biologics Private Limited) Regd. Office: 9th Floor, 901 to 905, Iscon Elegance, Circle P, S.G. Highway, Ahmedabad – 380015.  

To be sold by retail on the prescription of an Oncologist only.