Olanib150 mg

Breast Cancer: Olanib 150 mg is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy ... Read moreBreast Cancer: Olanib 150 mg is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before Olanib 150 mg treatment is initiated.Ovarian Cancer: Olanib 150 mg is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinumbased chemotherapy.

Targeted Cancer Therapy

Olanib 150 mg is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olanib 150 mg has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with Olanib 150 mg were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that Olanib 150 mg-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

There is a risk of medication errors between Olanib 150 mg tablets and Olanib 150 mg capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olanib 150 mg tablets and not Olanib 150 mg capsules. Prescribers should specify the formulation and dosage of Olanib 150 mg on each prescription.The recommended total daily dose of Olanib 150 mg tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.For treatment of ovarian cancer: Patients should start treatment with Olanib 150 mg no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olanib 150 mg therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).It is recommended that Olanib 150 mg treatment be continued until progression of the underlying disease or unacceptable toxicity. Olanib 150 mg should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olanib 150 mg.

There is a risk of medication errors between Olanib 150 mg tablets and Olanib 150 mg capsules. In order to minimize this risk, check the bottle labels to ensure that the drug being prepared and dispensed is Olanib 150 mg tablets and not Olanib 150 mg capsules. Prescribers should specify the formulation and dosage of Olanib 150 mg on each prescription.The recommended total daily dose of Olanib 150 mg tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction.For treatment of ovarian cancer: Patients should start treatment with Olanib 150 mg no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting Olanib 150 mg therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1).It is recommended that Olanib 150 mg treatment be continued until progression of the underlying disease or unacceptable toxicity. Olanib 150 mg should not be given in combination with other anti cancer therapy. Grapefruit or other similar fruit juices that are known to inhibit CYP3A should not be consumed while taking Olanib 150 mg.

Clinical studies of Olanib 150 mg in combination with other anti-cancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. The recommended Olanib 150 mg monotherapy dose is not suitable for combination with myelosuppressive anti-cancer agents. Olanib 150 mg is predominantly metabolised by CYP3A. Co-administered CYP3A inhibitors or inducers may respectively increase or decrease Olanib 150 mg plasma concentration.

Olanib 150 mg is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation.

The most common serious adverse reaction reported was anemia (2.4% Olanib 150 mg vs 2.2% chemotherapy). The following serious ADRs were reported in one patient each: dermatitis allergic, neutrophil count decreased and platelet count decreased. The proportion of patients who permanently discontinued Olanib 150 mg due to adverse events was 4.9% in the Olanib 150 mg arm compared with 7.7% in the chemotherapy arm. Anemia and platelet count decrease were the only adverse reactions leading to discontinuation of Olanib 150 mg in more than one patient.

Pregnancy: Olanib 150 mg can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olanib 150 mg wasteratogenic 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 Olanib 150 mg 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 Olanib 150 mg, 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.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): occurred in patients exposed to Olanib 150 mg, and the majority of reports were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.Pneumonitis: occurred in patients exposed to Olanib 150 mg, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.Embryo-Fetal Toxicity: Olanib 150 mg can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception

There is no specific treatment in the event of Olanib 150 mg overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat symptomatically.

Store in a dry place below 30°C, protect from light. Keep out of the reach of children.

Pediatric Use: The safety and efficacy of Olanib 150 mg has not been established in pediatric patients.

Targeted Cancer Therapy

Olanib 150 mg is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olanib 150 mg has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with Olanib 150 mg were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that Olanib 150 mg-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.

Pregnancy: Olanib 150 mg can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. Olanib 150 mg wasteratogenic 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 Olanib 150 mg 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 Olanib 150 mg, 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.

Pediatric Use: The safety and efficacy of Olanib 150 mg has not been established in pediatric patients.