Olaparib

Olaparib is a prescription medication used for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and metastatic castration-resistant prostate cancer.

• Olaparib is available under the following different brand names: Lynparza

Adult dosage

Tablet

• 100mg
• 150mg

Ovarian Cancer 

• Recurrent ovarian cancer: 300 mg orally twice daily
• Advanced ovarian cancer (monotherapy): 300 mg orally twice daily
• Advanced ovarian cancer (combination therapy)
  • Olaparib 300 mg orally twice daily, plus
  • Bevacizumab 15 mg/kg IV every 3 weeks for a total of 15 months (including with chemotherapy and as maintenance)
• Advanced ovarian cancer (after more than 3 lines of chemotherapy): 300 mg orally twice daily

Breast cancer

• 300 mg orally twice daily

Pancreatic cancer

• 300 mg orally twice daily

Metastatic castration-resistant prostate cancer

• 300 mg orally twice daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Olaparib include:

• low levels of iron in the blood (anemia),
• nausea,
• fatigue,
• weakness,
• vomiting,
• diarrhea,
• distortion of taste,
• indigestion,
• headache,
• decreased appetite,
• common cold-like symptoms (runny nose, sneezing, sore throat, upper respiratory infection),
• cough,
• joint and muscle pain,
• back pain,
• skin irritation or rash, and
• abdominal pain or discomfort.

Serious side effects of Olaparib include:

• hives,
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• fever, chills, weakness, 
• feeling light-headed or very tired,
• mouth and skin sores,
• easy bruising, unusual bleeding,
• pain or burning while urinating, 
• blood in the urine or stools,
• pale skin, cold hands, and feet,
• weight loss,
• cough, 
• wheezing, and
• shortness of breath.

Rare side effects of Olaparib include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Olaparib has severe interactions with no other drugs.
• Olaparib has serious interactions with at least 88 other drugs:
• Olaparib has moderate interactions with at least 93 other drugs
• Olaparib has minor interaction with no other drugs:

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Olaparib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Olaparib?”

Cautions

• Pneumonitis, including fatal cases, occurred in less than 1%; interrupt treatment if pneumonitis is suspected; discontinue if pneumonitis is confirmed; if patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt treatment and promptly assess the source of symptoms; if pneumonitis confirmed, discontinue treatment and treat patient appropriately
• Can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals; (see Pregnancy)
• Venous thromboembolic events, including pulmonary embolism, occurred in mCRPC patients who were treated with olaparib and androgen deprivation therapy; monitor for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated
• Myelodysplastic syndrome/ acute myeloid leukemia
• Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) occurred in clinical trials
• Monitor complete blood cell count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment
• Do not initiate treatment until hematological toxicity caused by previous chemotherapy (Grade less than or equal to 1) resolves
• For prolonged hematological toxicities, interrupt treatment and promptly assess the source of symptoms; monitor blood counts weekly until recovery
• If levels have not recovered to Grade less than 1 after 4 weeks, refer to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics
• All patients with myelodysplastic syndrome reported to have received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy; some of these patients also had a history of more than one primary malignancy or of bone marrow dysplasia
• If MDS/AML is confirmed, discontinue Olaparib

Pregnancy and Lactation

• Based on findings in animals and mechanism of action, fetal harm may occur when administered to a pregnant woman; there is no available data on use in pregnant women to inform of drug-associated risk
• Olaparib 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

Contraception

• In women of childbearing potential, avoid pregnancy by using effective contraception during treatment and for at least 6 months after receiving the last dose; pregnancy testing is recommended for females of reproductive potential prior to initiating treatment
• Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of Olaparib
• Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Olaparib

Lactation

• No data are available regarding the presence of olaparib in human milk, or on effects on the breastfed infant or on milk production; because of potential for serious adverse reactions in breastfed infants from therapy, advise lactating women not to breastfeed during treatment and for 1 month after receiving the last dose