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For the use of a Registered Medical Practitioner only. Relugolix Tablets 120 mg (RexigoTM).

Indication: Relugolix tablets 120 mg are indicated for the treatment of adult patients with advanced prostate cancer.

Recommended Dosage & Schedule: Initiate treatment of Relugolix with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day. Patients are advised to take a missed dose of relugolix as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. If treatment with relugolix is interrupted for greater than 7 days, restart relugolix with a loading dose of 360 mg on the first day and continue with a dose of 120 mg once daily.

Method of Administration: Relugolix can be taken with or without food. patients to swallow tablets whole and not to crush or chew tablets

Monitoring: Treatment with Relugolix should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.

Drugs interactions:

a) P-gp inhibitors.

b) Combined P-gp and Strong CYP3A Inducers. Dose Modification for Use with P-gp Inhibitors: Avoid co-administration of relugolix with P-gp inhibitors. If co-administration is unavoidable, take relugolix first and separate dosing by at least 6 hours. Treatment with relugolix may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required. Dose Modification for Use with Combined P-gp and Strong CYP3A Inducers: Avoid co-administration of relugolix with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the relugolix dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended relugolix dose of 120 mg once daily.

Special populations:

a) Renal impairment: No dose adjustment in patients with mild, or moderate renal impairment is required. Caution is warranted in patients with severe renal impairment.

b) Hepatic impairment: No dose adjustment in patients with mild or moderate hepatic impairment is required.

Contraindications: Relugolix tablets 120 mg is contraindicated in case of hypersensitivity to active substance or to any component of the formulation.

Use in special populations:

a) Pregnancy: There is a limited amount of data from the use of relugolix in pregnant women.

b) Lactation: Results from non-clinical studies indicate that relugolix is excreted into the milk of lactating rats.

c) Pediatric use: There is no relevant use of Relugolix in children and adolescents under 18 years of age for the indication of treatment of advanced hormone-sensitive prostate cancer.

d) Geriatric use: No dose adjustment in elderly patients is required. Side effect

profile: The most commonly observed adverse reactions during relugolix therapy are physiological effects of testosterone suppression, including hot flushes (54%), musculoskeletal pain (30%), and fatigue (26%). Other very common adverse reactions include diarrhoea and constipation (12% each). Fatigue and dizziness are very common (fatigue) and common (dizziness) adverse reactions that may influence the ability to drive and use machines. Storage: Store below 30ºC. Protect from moisture. For detailed information kindly refer to product monograph.

Enzalutamide Capsules IP 40mg/80mg for oral use.

INDICATIONS AND USAGE: Enzalutamide is indicated for the treatment of adults with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

DOSAGE FORM & STRENGTH: Enzalutamide Soft Gelatin Capsules IP 40mg/80mg.

DOSAGE AND ADMINISTRATION: The recommended dose is 160 mg enzalutamide (Four 40mg capsules/ Two 80mg capsules) as a single oral daily dose. Enzalutamide capsules can be taken with or without food. The capsules should be swallowed whole with water and it should not be chewed, dissolved or opened. Medical castration with a Luteinizing Hormone Releasing Hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.

CONTRAINIDCATIONS: Patients with hypersensitivity to active substance or any component of the Enzalutamide formulation and pregnancy.

WARNINGS AND PRECAUTIONS: Use cautiously in patients with a history of seizures or other predisposing factors such as underlying brain injury, stroke, primary brain tumours or brain metastases, alcoholism or concomitant seizure provoking medications. Discontinuation of enzalutamide is recommended in patients who develop posterior reversible encephalopathy syndrome (PRES). 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 clinicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Enzalutamide therapy. The safety and efficacy of concomitant use of enzalutamide with cytotoxic chemotherapy has not been established. However, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded. Caution is advised while treating patients with severe renal impairment (CrCL < 30 mL/min) or end-stage renal disease. An increased drug half-life has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.

USE IN SPECIFIC POPULATIONS: Enzalutamide capsules are not for use in pregnant, lactating women and paediatric population.

ADVERSE REACTIONS: More common (≥10%) adverse reactions are asthenia/fatigue, back pain, arthralgia, musculoskeletal pain, decreased appetite, constipation, diarrhoea, headache, hot flush, upper respiratory tract infection, peripheral oedema, dyspnoea, decreased weight, hypertension and dizziness/vertigo.

STORAGE: Store below 30°C. Protect from light and moisture. Please refer to the full prescribing information before prescribing OBNYX.

For the use of a Registered Oncologist or Hospital or Laboratory only. Pertuzumab Injection 420 mg / 14 ml (SIGRIMA™).

Indications: Pertuzumab is indicated for, 1) Metastatic Breast Cancer (MBC) – Pertuzumab along with trastuzumab and docetaxel is indicated for the treatment of patients having HER2-positive metastatic breast cancer and those who have not received prior anti-HER2 treatment or chemotherapy for metastatic breast cancer. 2) Early Breast Cancer (EBC) – Pertuzumab along with trastuzumab and chemotherapy is indicated for, a) Neoadjuvant treatment in patients having HER2-positive, inflammatory, locally advanced, or early-stage breast cancer (larger than 2 cm in diameter or node positive) as part of a whole treatment for early breast cancer. b) Adjuvant treatment of patients with HER2-positive who are at a high recurrence risk.

Method of administration: The initial dose administered for pertuzumab is 840 mg intravenously with 60-minute infusion period, followed by the intravenous administration (30 to 60 minutes) of a dose of 420 mg every 3 weeks. Pertuzumab, trastuzumab, and taxane must be administered consecutively. Taxane must be administered after administering pertuzumab and trastuzumab. Pertuzumab and trastuzumab must be administered after completion of anthracycline in patients who are on anthracycline-based regimen.

Contraindications: Pertuzumab is not recommended in patients with known hypersensitivity to pertuzumab or to any of the excipients of the drug product.

Use in Special populations:

a) Pregnancy: Patients must be informed of potential risks of pertuzumab to a fetus. There are clinical considerations if pertuzumab is used in combination with trastuzumab during pregnancy or within 7 months prior to conception. The assessed risk of major birth defects and miscarriage for the indicated population is not known.

b) Breast-feeding: a judgment should be made by considering the developmental and health benefits of breastfeeding, mother’s need of pertuzumab treatment, and any potential adverse events in breastfed child (driven by pertuzumab or underlying maternal condition).

c) Females and Males of Reproductive Potential: Pregnant women and those with reproductive potential should be informed that exposure to pertuzumab in combination with trastuzumab during pregnancy or within 7 months prior to conception may result in fetal harm, including embryo-fetal death or major birth defects.

d) Pediatric use: Efficacy and safety of pertuzumab remain unstudied in pediatric population.

e) Geriatric use: In patients aged ≥65 years and ≥75 years who received pertuzumab, the most common (≥10%) Grade 3-4 adverse reactions were neutropenia (22% and 23%, respectively), febrile neutropenia (12% and 13%, respectively), anemia (15% ≥75 years), and diarrhea (15% and 17%, respectively).  

f) Renal Impairment: Pertuzumab dose adjustments are not required in patients with mild (creatinine clearance [CLcr] 60 to 90 mL/min) or moderate (CLcr 30 to 60 mL/min) renal impairment. For patients with severe renal impairment (CLcr less than 30 mL/min), dose adjustment cannot be recommended due to limited pharmacokinetics data availability.

g) Hepatic Impairment: Clinical studies determining the impact of hepatic impairment on the efficacy and safety of pertuzumab are not available.

Adverse effects: The most frequently reported treatment-emergent adverse events (TEAEs) (reported in >10% of subjects) were diarrhea, vomiting, pyrexia, alopecia, and rash. The TEAEs reported in >2% of subjects that considered to be related to the study medication were anemia, constipation, diarrhea, nausea, stomatitis, vomiting, asthenia, chills, fatigue, pain, pyrexia, hypersensitivity, myalgia, headache, peripheral neuropathy, alopecia, pruritus, and rash. The serious TEAEs reported in >1% subject were febrile neutropenia, diarrhea and gastroenteritis.

WARNING: Left ventricular dysfunction: Pertuzumab may lead to subclinical and clinical cardiac failure, manifesting as decreased LVEF and CHF. Hence, it is important to evaluate cardiac function prior to and during treatment. If a clinically significant decrease in LVEF is observed, discontinue pertuzumab. Dose adjustments are mentioned the package insert.

Drug interactions: No drug-drug interactions were observed between pertuzumab and docetaxel, carboplatin or paclitaxel, pertuzumab, and trastuzumab.

Storage: Store at 2 − 8 °C. Do not freeze or shake. Protect from light.

For detailed information kindly refer to full prescribing information.