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These brands contain the same active ingredient (Olaparib). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Juparib 150 is indicated for:
Pharmacology
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2 and PARP3. These enzymes take part in normal cell functions such as DNA transcription, cell cycle regulation and DNA repair. In laboratory studies, olaparib slowed the growth of some tumour cell lines. It also decreased tumour growth in mouse xenograft models of human cancer, both as monotherapy and following platinum-based chemotherapy. Cytotoxicity and anti-tumour activity were greater in cell lines and mouse tumour models with deficiencies in BRCA. In vitro studies have shown that the cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, which disrupts cellular homeostasis and leads to cell death.
Absorption: When olaparib is taken by mouth as the capsule, it is absorbed quickly, and peak plasma concentrations are usually reached 1 to 3 hours after the dose. With repeated dosing there is no marked accumulation (accumulation ratio of 1.4 to 1.5 for twice daily dosing), and steady state exposure is reached within 3 to 4 days. Limited data suggest that systemic exposure (AUC) rises less than proportionally with dose over the range of 100 to 400 mg, though the PK data varied across trials. A high fat meal slowed the rate of absorption (Tmax delayed by 2 hours) but did not significantly change how much was absorbed (mean AUC increased by approximately 20%).
Distribution: After a single 400 mg dose, the mean (± standard deviation) apparent volume of distribution at steady state was 167 ± 196 L. In vitro protein binding is approximately 82%.
Metabolism: In vitro, CYP3A4/5 were shown to be the enzymes mainly responsible for metabolising olaparib. In female patients given oral 14C-olaparib, unchanged drug made up most of the circulating radioactivity in plasma (70%). The drug was extensively metabolised, and unchanged drug accounted for 15% of radioactivity in urine and 6% in faeces. Most of the metabolism is by oxidation, and a number of the products then go on to glucuronide or sulfate conjugation.
Excretion: After a single 400 mg dose, the mean (± standard deviation) terminal plasma half-life was 11.9 ± 4.8 hours and the apparent plasma clearance was 8.6 ± 7.1 L/h. After a single dose of 14C-olaparib, 86% of the radioactivity was recovered within a 7-day collection period, 44% in urine and 42% in faeces. Most of it was excreted as metabolites.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Important Dosage Information
DO NOT substitute Olaparib capsules (50 mg) with Olaparib tablets (100 mg and 150 mg) on a milligram-to-milligram basis. The two formulations differ in dosing and bioavailability.
Recommended Dosing
The recommended dose of Olaparib is 400 mg (eight 50 mg capsules) taken orally twice daily, with or without food. That gives a total daily dose of 800 mg. Continue treatment until disease progression or unacceptable toxicity. If a patient misses a dose of Olaparib, tell them to take the next dose at its scheduled time. Swallow the capsule whole. Do not chew, dissolve or open it. Do not take capsules that look deformed or show any sign of leakage.
Dosage Modifications for Adverse Reactions
To manage adverse reactions, consider interrupting treatment or reducing the dose. The recommended dose reduction is 200 mg (four 50 mg capsules) taken twice daily, for a total daily dose of 400 mg. If a further reduction is needed, go down to 100 mg (two 50 mg capsules) taken twice daily, for a total daily dose of 200 mg.
Dose Modifications for Use with CYP3A Inhibitors
Avoid using strong and moderate CYP3A inhibitors together with Olaparib, and consider alternative agents that inhibit CYP3A less. If the inhibitor can't be avoided, reduce the Olaparib dose to 150 mg (three 50 mg capsules) taken twice daily for a strong CYP3A inhibitor, or to 200 mg (four 50 mg capsules) taken twice daily for a moderate CYP3A inhibitor.
Dose Modifications for Patients with Renal Impairment
Patients with mild renal impairment (ClCr 51-80 mL/min as estimated by the Cockcroft-Gault equation) don't need any adjustment in Olaparib dosing. For moderate renal impairment (ClCr 31-50 mL/min), the recommended dose reduction is to 300 mg (six 50 mg capsules) twice daily, for a total daily dose of 600 mg. The pharmacokinetics of Olaparib have not been evaluated in patients with severe renal impairment or end-stage renal disease (ClCr ≤30 mL/min). Or as directed by the registered physician.
Pediatric Use
The safety and efficacy of Olaparib have not been established in pediatric patients.
Side Effects
Anemia was the most common serious adverse reaction with Olaparib, reported in 2.4% of patients on Olaparib and 2.2% on chemotherapy. Three other serious ADRs (adverse drug reactions) were each reported in one patient only: dermatitis allergic, neutrophil count decreased and platelet count decreased. Some patients stopped Olaparib for good because of adverse events. This was 4.9% in the Olaparib arm, compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions that led to stopping Olaparib in more than one patient.
Cautions & Contraindications
Warnings & Precautions
Myelodysplastic Syndrome/Acute Myeloid Leukemia In clinical trials, including long-term follow up, Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) occurred in <1.5% (21/1680) of patients treated with Olaparib monotherapy, and most of these events had a fatal outcome. Of the 21 patients, 19 had a documented BRCA mutation, 1 had gBRCA wildtype and in 1 the BRCA mutation status was unknown. More cases of MDS/AML have been documented in patients given Olaparib in combination studies. Among patients who developed secondary MDS/cancer-therapy related AML, the duration of therapy with Olaparib varied from < 6 months to > 2 years. All of them had earlier received chemotherapy with platinum agents and/or other DNA damaging agents, including radiotherapy. Some also had a history of previous cancer or bone marrow dysplasia. Don't start Olaparib until the patient has recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Check the complete blood count for cytopenia at baseline and then monthly, looking for clinically significant changes during treatment. If hematological toxicity is prolonged, interrupt Olaparib and check blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and a blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Olaparib. Pneumonitis Pneumonitis, including fatal cases, occurred in <1% of patients treated with Olaparib. If a patient has new or worsening respiratory symptoms such as dyspnea, cough and fever, or a radiological abnormality appears, interrupt the treatment and promptly assess the source of the symptoms. If pneumonitis is confirmed, discontinue Olaparib and treat the patient appropriately.
Contraindications
Olaparib must not be given to anyone who is hypersensitive to the medicine itself or to any ingredient in its formulation.
Pregnancy & Breastfeeding
Pregnancy
Olaparib can harm an unborn baby when given to a pregnant woman. This is based on how the medicine works and on what was seen in animals. In rats, olaparib was teratogenic and caused toxicity to the embryo and fetus at exposures below those in patients taking the recommended human dose of 400 mg twice daily. If olaparib is used during pregnancy, or if a patient becomes pregnant while taking it, she should be told about the possible danger to the baby and the possible risk of losing the pregnancy.
Nursing mothers
It is not known whether olaparib passes into human milk. Many drugs do pass into breast milk, and olaparib could cause serious side effects in a nursing baby. So a decision has to be made either to stop nursing or to stop the medicine, taking into account how important the medicine is for the mother.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
There's no specific treatment for an Olapar overdose, and the symptoms of an overdose haven't been established. If it happens, doctors should give general supportive care and treat whatever symptoms appear.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Olaparib in a dry place where the temperature stays below 30°C, and protect it from light. Keep it out of the reach of children.
Drug Interactions
Common questions about Juparib 150 150 mg
What is Juparib 150 150 mg Tablet?
Juparib 150 150 mg Tablet is a medicine that contains Olaparib. It is made by Jenphar Bangladesh Ltd. It belongs to the Targeted Cancer Therapy group of medicines.
What is Juparib 150 used for?
Juparib 150 is used for: Cancer.
What are the side effects of Juparib 150?
Anemia was the most common serious adverse reaction with Olaparib, reported in 2.4% of patients on Olaparib and 2.2% on chemotherapy. Three other serious ADRs (adverse drug reactions) were each reported in one patient only: dermatitis allergic, neutrophil count decreased and platelet count decreased.
Can I take Juparib 150 during pregnancy or while breastfeeding?
Pregnancy Olaparib can harm an unborn baby when given to a pregnant woman. This is based on how the medicine works and on what was seen in animals. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Juparib 150?
There's no specific treatment for an Olapar overdose, and the symptoms of an overdose haven't been established. If it happens, doctors should give general supportive care and treat whatever symptoms appear. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Juparib 150?
Keep Olaparib in a dry place where the temperature stays below 30°C, and protect it from light. Keep it out of the reach of children.
Can I take other medicines with Juparib 150?
Some medicines can interact with Olaparib, for example: Erythromycin, Imatinib, Carbamazepine, Ciprofloxacin, Clarithromycin, Telithromycin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Juparib 150?
Juparib 150 is a prescription (Rx) medicine. Take it as your doctor advises.