Linparib® (Olaparib)

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Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3.

INDICATIONS

Linparib® is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

Ovarian cancer
• for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
• in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
o a deleterious or suspected deleterious BRCA mutation, and/or
o genomic instability.
Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
• for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.

Breast cancer
• for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
• for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
Pancreatic cancer
• for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
Prostate cancer
• for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.
• in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Linparib®.

It is not known if Lynparza is safe and effective in children.

DOSAGE AND ADMINISTRATION The dosage of Linparib® is determined by your healthcare provider, but the usual dosage of Linparib® is as follows:
• Recommended dosage is 300 mg taken orally twice daily with or without food.
• Patients receiving Linparib® for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

WARNINGS AND PRECAUTIONS

Linparib® may cause serious side effects including:
• Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).

• Lung problems (pneumonitis).

• Blood clots (Venous Thromboembolism).

DRUG INTERACTIONS

Since the drug interactions with Linparib® are not limited to the following medicines tell your healthcare provider or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and other medicines you bought without a prescription.
This is because Linparib® can affect the way some other medicines work. Also, some other medicines can affect the way Linparib® works.
• any other anticancer medicines
• a vaccine or a medicine that suppresses the immune system, as you may need to be closely
• monitored
• itraconazole, fluconazole - used for fungal infections
• telithromycin, clarithromycin, erythromycin - used for bacterial infections
• protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine,
• efavirenz - used for viral infections, including HIV
• rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
• phenytoin, carbamazepine, phenobarbital - used as a sedative or to treat fits (seizures) and
• epilepsy
• herbal remedies containing St John’s Wort (Hypericum perforatum) - used mainly for
• depression
• digoxin, diltiazem, furosemide, verapamil, valsartan - used to treat heart conditions or high
• blood pressure
• bosentan - used to treat pulmonary artery hypertension
• statins, for example simvastatin, pravastatin, rosuvastatin - used to lower blood cholesterol
• levels
• dabigatran – used to thin the blood
• glibenclamide, metformin, repaglinide - used to treat diabetes
• ergot alkaloids - used to treat migraines and headaches
• fentanyl - used to treat cancer pain
• pimozide, quetiapine - used to treat mental health problems
• cisapride - used to treat stomach problems
• colchicine – used to treat gout
• cyclosporine, sirolimus, tacrolimus - used to suppress the immune system
• methotrexate - used to treat cancer, rheumatoid arthritis and psoriasis.

Lynparza with drink
Do not drink grapefruit juice while you are being treated with Lynparza. It can affect the way the medicine works.

Linparib

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