Olaparib is an FDA-approved targeted therapy for cancer. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase, an enzyme involved in DNA repair. It acts against cancers in people with hereditary BRCA1 or BRCA2 mutations, which include some ovarian, breast, and prostate cancers.
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Olanib 50mg (Olaparib) 112 Capsule
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Presentation
Olanib Capsule: Each hard gelatin capsule contains Olaparib INN 50 mg.
Descriptions
Olaparib is an inhibitor of the mammalian polyadenosine 5‘-diphosphoribose polymerase (PARP) enzyme.
The chemical name is 4-[(3-{[4-(cyclopropylcarbonyl)piperaz- in—1-y|]carbonyI)—4-f|uorophenyl)methyl]phthalazin-1(2H)—one and it has the following chemical structure:
The empirical molecular formula for Olaparib is C24H23FN403 and the relative molecular mass is 434.46.
Olaparib is a crystalline solid, is non-chiral and shows pH- independent low solubility of approximately 0.1 mg/mL across the physiological pH range.
Olanib (Olaparib) is available in 50 mg capsules for oral administration. Each capsule contains Olaparib as the active ingredient and required pharmaceutical excipients.
Indications
Olaparib (Olanib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germ line BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
Dosage & Administration
The recommended dose of Olaparib (Olanib) is 400 mg (eight 50 mg capsules) taken twice daily, for a total daily dose of 800 mg. Continue treatment until disease progression or unaccept- able toxicity.
If a patient misses a dose of Olaparib (Olanib), instruct patient to take their next dose at its scheduled time.
Swallow capsule whole. Do not chew, dissolve, or open capsule. Do not take capsules which appear deformed or show evidence of leakage.
Dose Adjustments for Adverse Reactions
To manage adverse reactions, consider dose interruption of treatment or dose reduction.
The recommended dose reduction is to 200 mg (four 50 mg capsules) taken twice daily, for a total daily dose of 400 mg.
If a further final dose reduction is required, then reduce 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 concomitant use of strong and moderate CYP3A inhibitors and consider alternative agents with less CYPA inhibition. If the inhibitor cannot be avoided, reduce the Olaparib (Olanib) dose to 150 mg (three 50 mg capsules) taken twice daily for a strong CYP8A inhibitor or 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 Cockcroft-Gault) do not require an adjustment in Olaparib (Olanib) dosing. In patients with moderate renal impairment (CLcr 31-50 mL/min) the recommended dose reduction is to 300 mg (six 50 mg capsules) taken twice daily, for a total daily dose of 600 mg. The pharmacokinetics of Olaparib (Olanib) have not been evaluated in patients with severe renal impairment or end-stage renal disease (CLcr <30 mL/min).
Side Effects
- Nausea or vomiting
- Tiredness or
- weakness
- Diarrhea
- Headache
- Changes in kidney
- function blood tests
- Low number of platelets
- Changes in the way food tastes
- Loss of appetite
- Low number of red or white blood cells
- Mouth sores
Precautions
Myelodysplastic Syndrome/Acute Myeloid Leukemia Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been confirmed in 6 out of 298 (2%) patients enrolled in a single arm trial of Olaparib monotherapy, in patients with deleteri- ous or suspected deleterious germline BRCA-mutated (gBRCAm) advanced cancers. In a randomized placebo controlled trial, MDS/AML occurred in 3 out of 136 (2%) patients with advanced ovarian cancer treated with Olaparib. Overall, MDS/AML were reported in <1% patients treated with Olaparib in clinical studies. The majority of MDS/AML reports were fatal, and the duration of therapy with Olaparib in patients who developed secondary MDS/ cancer- therapy related AML varied from <6 months to >2 years. All of these patients had previous chemother- apy with platinum agents and/or other DNA damaging agents including radiotherapy. Some of these patients also had a history of previous cancer or of bone marrow dysplasia.
Monitor complete blood count testing at baseline and monthly thereafter. Do not start Olaparib (Olanib) until patients have recovered from hematological toxicity caused by previous chemotherapy (CTCAE Grade 1). For prolonged hematological toxicities, interrupt Olaparib (Olanib) and monitor blood counts weekly until recovery. If the levels have not recovered to CTCAE Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Olaparib (Olanib).
Contraindications
CONTRAINDICATIONS Hypersensitivity to Olaparib or to any of the excipients.
Use in Pregnancy & Lactation
Pregnancy
Pregnancy category is D. Olaparib (Olanib) can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olaparib (Olanib) was teratogenic and caused embryo-fetal toxicity in rats at exposures below those in patients receiving the recommended human dose of 400 mg twice daily. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for loss of the pregnancy.
Nursing Mothers
It is not known whether Olaparib (Olanib) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Olaparib (Olanib), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Populations With Reproductive Potential
Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Olaparib.
Olaparib (Olanib) can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use highly effective contraception during treatment with Olaparib (Olanib) and for at least 6 months following the last dose.
Pediatric Use The safety and efficacy of Olaparib (Olanib) has not been established in pediatric patients.
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Drug Interaction
Anticancer Agents
Clinical studies of Olaparib in combination with other myelosup- pressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
Drugs that may Increase Olaparib Plasma Concentrations Olaparib (Olanib) is primarily metabolized by CYP3A. Avoid concomitant use of strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritinovir, lopinavir/ritinovir, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythro- mycin, fluconazole, fosamprenavir, imatinib, verapamil). If the strong or moderate CYP3A inhibitors must be co-administered, reduce the dose of Olaparib (Olanib). Avoid grapefruit and Seville oranges during Olaparib (Olanib) treatment.
Drugs that may Decrease Olaparib (Olanib) Plasma Concentrations
Avoid concomitant use of strong CYP3A inducers (e.g., phenyto- in, rifampicin, carbamazepine, St. John’s Wort) and moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin). If a moderate CYP3A inducer cannot be avoided, be aware of a potential for decreased efficacy of Olaparib (Olanib).
Commercial Packaging
Olanib 50: Each bottle contains 112 capsules
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