Olaparib

The recommended dosage is 300 mg by mouth orally twice daily with or without food. Patients receiving Olaparib 150 mg tablets for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. For moderate renal impairment (CLcr 31-50 mL/min), reduce Olaparib dosage to 200 mg by mouth twice daily.

Take Olaparib by mouth 2 times daily. Each dose must be taken approximately 12 hours apart. Swallow tablets whole. Do not crush, chew, dissolve, or divide the pills. Take tablets with or without food exactly as your healthcare provider tells you. Do not take excess than 4 tablets in a single day.

Taking Olaparib for early breast cancer and have hormone receptor-positive disease, continue to take hormonal therapy throughout your treatment with Olaparib.

Taking Olaparibfor for prostate cancer and receiving gonadotropin-releasing hormone (GnRH) analog therapy, continue with this treatment throughout your treatment with Olaparib unless you have had a surgery to scale down the existence of testosterone in the body (surgical castration).

If you miss/skip a dose of Olaparib, take your very next dose at about usual scheduled time. Do not take an aditional dose to make up for a missed/skipped dose. If you take excess Olaparib, call your healthcare professional or go to the nearest hospital emergency room promptly.

The most commonly reported side effects with Olaparib as a single agent include: vomiting, nausea, fatigue, anemia, diarrhea, decreased appetite, cough, headache, neutropenia, abdominal pain upper, dysgeusia, dyspnea, dizziness, dyspepsia, leukopenia, and thrombocytopenia.

Side effects of Olaparib in combination with bevacizumab were fatigue, nausea, anemia, lymphopenia, diarrhea, vomiting, neutropenia, urinary tract infection, leukopenia, and headache.

• Do not initiate treatment with lynparza 150 mg tablets until patients have recovered from the hematological toxicity caused by prior chemotherapy. Monitor complete blood count (CBC) for cytopenia at baseline and on monthly basis thereafter for clinically significant changes during treatment.
• For prolonged hematological toxicities, interrupt treatment and monitor blood counts on weekly basis until recovery. In case the levels have not recovered to Grade-1 or less after four weeks, the respective patient should be referred to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS or AML is confirmed, discontinue therapy.
• For patients with various cancers who received Olaparib treatment as a single agent, the incidence of pneumonitis, including fatal cases, was reported. If new or worsening respiratory symptoms such as cough, dyspnea, fever, or a radiological abnormality occur, interrupt treatment and promptly evaluate the source of the signs/symptoms. If pneumonitis is confirmed, discontinue treatment and treat the patient appropriately.
• Several thromboembolic events, including pulmonary embolism, may occur in patients with metastatic castration-resistant prostate cancer who take lynparza 100 mg tablets plus androgen deprivation therapy. Monitor patients for signs/symptoms of venous thrombosis and pulmonary embolism and treat as medically required, which may include long-term anticoagulation as clinically mentioned.
• Olaparib can be responsible for causing fetal harm when administered to a pregnant woman on behalf of its mechanism of action and findings in animals. Respective females of reproductive age/potential should use appropriate contraception throughout treatment and for six months following the final dose of Olaparib.
• No information is available regarding the existence of olaparib in human milk, or its effects on the breastfed child or on milk production. Because of the potential for severe side effects in the breastfed child from lynparza olaparib, lactating women should not breastfeed during treatment with this medicine and for 1-onth after receiving the final dose.

Olaparib is supplied as 150 mg and 100 mg tablets. Store at 20 to 25°C (68 to 77°F), excursions permitted to 15 to 30°C (59 to 86°F). Store these tablets in the original bottle in order to protect them from moisture.

• Coadministration of CYP3A inhibitors can increase the concentrations of Olaparib, which may increase the risk for side effects. Coadministration of strong/moderate CYP3A inhibitors is not recommended. If the strong/moderate inhibitor must be coadministered, reduce the dosage of Olaparib.
• Concomitant use with a strong/moderate CYP3A inducer decreased olaparib exposure, which may reduce the efficacy of Olaparib. Coadministration of strong/moderate CYP3A inducers is not recommended.