Olanib 50 MG (Olaparib INN )

Product Name : Olanib
Generic Name : Olaparib INN 50 mg
Formulation : Tablet
Available Pack Size : 30’s Pot
Available Strengths : 50 mg
Registrations : Export Only

Product Information

Olanib 50MG (Olaparib INN) is a potent and selective PARP (Poly ADP-Ribose Polymerase) inhibitor indicated for patients with BRCA1 or BRCA2-mutated cancers, including ovarian, fallopian tube, primary peritoneal, breast, prostate, and pancreatic cancers. Olaparib INN works by blocking PARP1 and PARP2 enzymes and trapping PARP-DNA complexes at sites of single-strand DNA breaks, exploiting the homologous recombination deficiency of BRCA-mutated tumour cells through the mechanism of synthetic lethality to selectively destroy cancer cells while sparing normal tissue. The 50mg tablet strength supports flexible, clinician-directed dosing across the full range of approved treatment protocols. For patients requiring a comprehensive range of targeted cancer therapies, Mediaid Pharmacy’s oncology and specialty medicines portfolio provides a complete selection of internationally sourced oncology treatments. Olanib 50MG (Olaparib INN) is available for export worldwide through Mediaid Pharmacy with worldwide shipping.

Basic Product Information of Olanib 50MG (Olaparib INN)

Brand Name Olanib 50MG (Olaparib INN)
Generic Name Olaparib INN
Drug Class PARP Inhibitor (Poly ADP-Ribose Polymerase Inhibitor)
Available Strength 50mg
Formulation Film-Coated Tablet
Pack Size 30 Tablets per Pot
Primary Indication BRCA1/2-Mutated Ovarian, Breast, Prostate, and Pancreatic Cancers
Regulatory Approvals USFDA Approved (Ovarian, Breast, Prostate, and Pancreatic Cancer). EMA Approved (Ovarian and Breast Cancer). Available for Export Only.
Originator Brand Lynparza by AstraZeneca and MSD (Merck)
Registration / Market Status Export Only
Global Supplier Mediaid Pharmacy Worldwide Shipping Available
Storage Conditions Store below 30°C in a dry place away from light and moisture. Keep out of the reach of children.

How Olanib 50MG (Olaparib INN) Works PARP Inhibition and Synthetic Lethality

Olaparib INN, the active ingredient in Olanib 50MG, is a selective and potent inhibitor of Poly ADP-Ribose Polymerase enzymes PARP1 and PARP2. PARP enzymes are central to the base excision repair (BER) pathway the mechanism cancer cells use to repair single-strand DNA breaks that occur during normal cellular replication. In patients with germline or somatic BRCA1 or BRCA2 mutations, the homologous recombination (HR) DNA repair pathway is already functionally defective, leaving BRCA-mutated tumour cells uniquely dependent on PARP-mediated BER for survival.

Olaparib blocks PARP1 and PARP2 catalytic activity and critically traps PARP-DNA complexes at sites of single-strand breaks, preventing their resolution and causing replication fork stalling and collapse. In BRCA-mutated tumour cells that cannot execute homologous recombination repair, the accumulation of unresolvable double-strand DNA breaks triggers apoptotic cancer cell death through the principle of synthetic lethality the concept that the combination of two individually non-lethal genetic defects produces lethal cellular dysfunction. Normal cells with intact BRCA1/BRCA2 function repair these breaks via homologous recombination, so Olaparib selectively destroys tumour cells while sparing healthy tissue. Mediaid Pharmacy’s oncology medicines catalogue includes a broad range of precision-targeted therapies that work alongside agents such as Olaparib in multidisciplinary cancer care.

The 50mg tablet strength of Olanib provides oncologists with a clinically essential dose-management tool. The full standard dose of Olaparib is 300mg (six 50mg tablets) taken twice daily. When dose reduction is required due to moderate renal impairment, co-administration of a moderate CYP3A inhibitor, or grade 3–4 haematological toxicity the 50mg tablet enables precise stepwise reductions to 200mg twice daily (four 50mg tablets) or 100mg twice daily (two 50mg tablets) without requiring the patient to split higher-strength tablets. In the landmark SOLO-1 trial, Olaparib maintenance therapy delivered a median progression-free survival (PFS) of 36.0 months versus 13.8 months on placebo in newly diagnosed BRCA-mutated advanced ovarian cancer a 70% reduction in risk of disease progression or death establishing Olaparib as the international standard-of-care PARP inhibitor in this setting.

Approved Indications for Olanib 50MG (Olaparib INN)

Olanib (Olaparib INN) 50mg is approved for the following clinical indications in adult patients with confirmed BRCA1 or BRCA2 mutations:

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Olaparib INN is USFDA and EMA approved as first-line maintenance therapy for adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Additionally approved for recurrent platinum-sensitive relapsed ovarian cancer maintenance and as monotherapy in germline BRCA-mutated platinum-sensitive relapsed disease.

HER2-Negative BRCA-Mutated Breast Cancer

USFDA and EMA approved for adult patients with deleterious or suspected deleterious germline BRCA1/2-mutated, HER2-negative locally advanced or metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Olaparib is additionally approved as adjuvant therapy for patients with high-risk early-stage BRCA-mutated HER2-negative breast cancer following standard platinum-containing or taxane-containing neoadjuvant or adjuvant chemotherapy.

BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

USFDA approved for adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Olaparib targets the homologous recombination repair deficiency that drives acquired treatment resistance in these patients.

BRCA-Mutated Metastatic Pancreatic Adenocarcinoma

USFDA approved as maintenance therapy for adult patients with deleterious or suspected deleterious germline BRCA1/2-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Olaparib is the first PARP inhibitor to receive regulatory approval for pancreatic cancer maintenance therapy.

Key Clinical Benefits of Olanib 50MG (Olaparib INN)

Precise Dose Flexibility with the 50MG Strength

The 50mg tablet strength gives oncologists the exact dose increments required by clinical guidelines for managing renal impairment, moderate CYP3A inhibitor interactions, and haematological toxicity. Reductions from 300mg to 200mg or 100mg twice daily are achieved cleanly without tablet splitting, supporting precise, protocol-compliant dose management.

Multi-Cancer USFDA and EMA Regulatory Approval

Olaparib INN holds USFDA approval across four distinct cancer types ovarian, breast, prostate, and pancreatic and EMA approval for ovarian and breast cancers, making Olanib one of the most broadly approved targeted oncology agents in a single oral formulation for BRCA-mutated malignancies.

Clinically Proven Progression-Free Survival Benefit

In the SOLO-1 trial, Olaparib maintenance achieved median PFS of 36.0 months versus 13.8 months on placebo in newly diagnosed BRCA-mutated advanced ovarian cancer a hazard ratio of 0.30 representing a 70% reduction in disease progression risk. The OlympiAD trial confirmed significant PFS benefit over standard chemotherapy in BRCA-mutated metastatic breast cancer.

Affordable Export-Grade Alternative to Lynparza

Olanib 50mg contains the same active ingredient as Lynparza (AstraZeneca and MSD) at a substantially lower cost. Patients and healthcare systems in markets across Asia, Africa, the Middle East, and beyond gain access to the same validated PARP inhibition mechanism without the financial burden of originator pricing, improving treatment access and long-term adherence.

Oral Administration No Infusion Required

Olanib is taken orally with or without food, eliminating the need for intravenous chemotherapy infusions and hospital-based administration visits. This oral route of delivery supports long-term maintenance therapy in the outpatient setting, reducing the healthcare system burden and improving patient quality of life during extended cancer treatment.

Bevacizumab Combination Option in Ovarian Cancer

Olaparib is approved in combination with Bevacizumab as first-line maintenance therapy for patients with HRD (Homologous Recombination Deficiency)-positive advanced ovarian cancer following response to first-line platinum-taxane chemotherapy with Bevacizumab, extending its utility in ovarian cancer beyond BRCA mutation status alone.

How to Take Olanib 50MG (Olaparib INN) Dosage Guidelines

Route of Administration: Oral taken by mouth with or without food at any consistent time of day. Olanib 50mg tablets should be swallowed whole and must not be crushed, dissolved, or chewed.

Standard Adult Dose: 300mg (six 50mg tablets) taken twice daily, equivalent to a total daily dose of 600mg. This standard dose applies across all approved cancer indications ovarian, breast, prostate, and pancreatic cancer.

First Dose Reduction: 200mg (four 50mg tablets) twice daily. Applied when grade 3 or 4 haematological or non-haematological toxicity requires dose modification, or when co-administration of a moderate CYP3A inhibitor cannot be avoided.

Second Dose Reduction: 100mg (two 50mg tablets) twice daily. Applied if further dose reduction is required following the first reduction due to persistent toxicity. Discontinue permanently if the patient cannot tolerate 100mg twice daily.

Moderate Renal Impairment (CrCl 31–50 mL/min): Reduce dose to 200mg (four 50mg tablets) twice daily. Olaparib is not recommended in patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease due to insufficient pharmacokinetic data.

Mild Renal Impairment (CrCl 51–80 mL/min): No dose adjustment required. Patients with mild renal impairment may receive the standard 300mg twice-daily dose.

Hepatic Impairment: No dose adjustment required for mild hepatic impairment (Child-Pugh Class A). Olaparib is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) due to the absence of pharmacokinetic and safety data in these populations.

Moderate CYP3A Inhibitor Co-Administration: If concurrent use with a moderate CYP3A inhibitor (such as fluconazole, erythromycin, or verapamil) cannot be avoided, reduce the Olaparib dose to 100mg (two 50mg tablets) twice daily and monitor closely for toxicity.

Paediatric Use: The safety and efficacy of Olaparib INN in patients under 18 years of age have not been established. Use in the paediatric population is not recommended.

Prescription Medication Pre-Treatment Blood Count Requirements. Treatment with Olanib (Olaparib INN) should not be initiated in patients with an Absolute Neutrophil Count (ANC) below 1.5 × 10⁹ cells per litre, a platelet count below 100 × 10⁹ cells per litre, or a haemoglobin value below 10 g/dL. Complete blood count (CBC) monitoring is mandatory before treatment initiation, monthly for the first 12 months of therapy, and periodically thereafter. Do not initiate Olaparib until haematological toxicity from any previous chemotherapy has fully recovered to Grade 1 or less. Always follow your prescribing oncologist’s instructions.

Clinical Monitoring Requirements During Olanib Treatment

Regular clinical monitoring is mandatory throughout Olanib (Olaparib INN) treatment. Oncologists must monitor for haematological toxicities, as Olaparib commonly causes anaemia, thrombocytopenia, neutropenia, and leukopenia. Mandatory monitoring parameters include Complete Blood Count (CBC) before treatment initiation, monthly for the first 12 months, and periodically during subsequent therapy; renal function via serum creatinine and estimated glomerular filtration rate (eGFR) at baseline and before any dose adjustment; and clinical assessment for signs of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML). Patients in whom MDS or AML is confirmed by specialist haematology evaluation must discontinue Olaparib permanently. Additionally, patients should be monitored for signs and symptoms of Pneumonitis a rare but potentially life-threatening pulmonary adverse reaction requiring immediate treatment interruption, specialist investigation, and permanent discontinuation if confirmed. Patients must report any fever, unusual breathlessness, persistent cough, chest pain, or unexplained fatigue to their oncologist without delay.

Drug Interactions and Important Safety Information for Olanib

Concomitant use of Olanib with strong CYP3A inhibitors including itraconazole, ketoconazole, clarithromycin, posaconazole, voriconazole, and cobicistat-containing antiretroviral regimens must be avoided. Strong CYP3A inhibition increases Olaparib plasma exposure by approximately 2.7-fold, significantly elevating toxicity risk. Grapefruit and Seville orange juice, which also inhibit CYP3A, must be avoided throughout the course of Olanib treatment. Moderate CYP3A inhibitors (fluconazole, erythromycin, verapamil, diltiazem) must also be avoided where possible; if unavoidable, the Olaparib dose must be reduced to 100mg (two 50mg tablets) twice daily with close toxicity monitoring.

Strong and moderate CYP3A inducers including rifampicin, phenytoin, carbamazepine, enzalutamide, and St. John’s Wort must be strictly avoided during Olanib therapy. These agents reduce Olaparib plasma concentrations by up to 87%, substantially compromising therapeutic efficacy. Patients must inform their oncologist of all prescription medications, over-the-counter medicines, vitamin supplements, and herbal products before initiating Olanib. Co-administration with other myelosuppressive agents or DNA-damaging drugs increases the risk of additive haematological toxicity and requires specialist evaluation before concurrent use.

Side Effects and Precautions of Olanib 50MG (Olaparib INN)

Common Side Effects

Anaemia (low red blood cell count)

Nausea and vomiting

Fatigue and asthenia

Neutropenia (low neutrophil count)

Thrombocytopenia (low platelet count)

Leukopenia (low white blood cell count)

Diarrhoea and abdominal pain or discomfort

Headache and dizziness

Decreased appetite

Dysgeusia (altered or reduced taste sensation)

Serious Warnings and Precautions

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukaemia (AML) rare but serious secondary haematological malignancies. Discontinue Olanib permanently if MDS or AML is confirmed on specialist haematology evaluation.

Pneumonitis rare but potentially fatal interstitial lung disease and pneumonitis have been reported. Interrupt treatment immediately on suspicion; discontinue permanently if pneumonitis is confirmed.

Venous Thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE). Use with caution in patients with known thrombotic risk factors.

Not recommended during pregnancy or breastfeeding. Female patients must use effective contraception during treatment and for at least six months after the final dose. Male patients must use effective contraception for three months after the final dose.

Strong and moderate CYP3A inhibitors and strong CYP3A inducers must be avoided; interactions significantly alter Olaparib plasma concentrations and either increase toxicity risk or reduce therapeutic efficacy.

Who Should Use Olanib 50MG (Olaparib INN)?

Olanib is indicated for adult patients diagnosed with BRCA1 or BRCA2-mutated cancers specifically advanced or recurrent ovarian, fallopian tube, or primary peritoneal cancer; HER2-negative locally advanced or metastatic breast cancer; high-risk early-stage BRCA-mutated HER2-negative breast cancer (adjuvant); BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC); and BRCA-mutated metastatic pancreatic adenocarcinoma across the full range of approved indications described above. The 50mg tablet strength is particularly valuable for patients requiring clinically guided dose reductions due to moderate renal impairment, moderate CYP3A inhibitor co-administration, or haematological toxicity management, as it enables precise stepwise dose adjustments to 200mg or 100mg twice daily without tablet manipulation. All patients must have a confirmed deleterious or suspected deleterious BRCA1 or BRCA2 mutation detected by a validated companion diagnostic before initiating treatment. Olanib is prescribed exclusively by oncologists and specialist physicians experienced in managing hereditary BRCA-associated cancers and precision oncology therapies. A thorough pre-treatment medical assessment including complete blood count (CBC), renal function tests, hepatic function tests, and BRCA biomarker testing is mandatory before initiating Olanib. For patients whose cancer management requires a broader range of targeted oncology agents, Mediaid Pharmacy’s oncology specialty medicines portfolio provides comprehensive access to internationally sourced precision cancer therapies.

Global Supplier: Mediaid Pharmacy Worldwide Shipping for Olanib 50MG (Olaparib INN)

Mediaid Pharmacy is a trusted global supplier of specialty, oncology, and targeted therapy medications. Olanib (Olaparib INN) 50mg is available through Mediaid Pharmacy for export worldwide, with reliable shipping to South Asia, the Middle East, Africa, Europe, Southeast Asia, and beyond. Our specialist team provides full order support including pricing quotations, stock availability confirmation, regulatory documentation, and end-to-end delivery tracking. Contact Mediaid Pharmacy directly via WhatsApp, phone, or WeChat for all enquiries regarding Olanib 50MG availability, pricing, and international delivery to your country.

Why Choose Olanib 50MG (Olaparib INN) from Mediaid Pharmacy?

Olanib 50MG represents a clinically important and cost-accessible formulation of one of oncology’s most rigorously validated precision therapies. As an export-grade generic equivalent of Lynparza by AstraZeneca and MSD, Olanib delivers the same active ingredient Olaparib INN with the same validated PARP1 and PARP2 inhibition mechanism and synthetic lethality in BRCA-deficient tumours, at a substantially more affordable price point than the originator brand. The 50mg tablet strength provides the critical dose-reduction increments that clinical guidelines require, making Olanib an operationally essential formulation for oncologists managing patients with renal impairment, drug interactions, or toxicity-driven dose adjustments. Distributed globally by Mediaid Pharmacy with reliable worldwide export shipping, Olanib gives patients and healthcare providers in regulated and emerging markets access to high-quality targeted cancer therapy without the financial barrier of brand-name pricing. For patients and oncology teams requiring a comprehensive suite of targeted cancer medicines across multiple indications, Mediaid Pharmacy’s oncology medicines section provides a full range of specialty oncology products sourced from verified international manufacturers. For any patient or oncologist seeking a proven, dose-flexible, affordable, and globally accessible Olaparib INN treatment option, Olanib 50MG from Mediaid Pharmacy is the trusted export-grade choice.

Frequently Asked Questions About Olanib 50MG (Olaparib INN)

What is Olanib 50MG (Olaparib INN) used for?

Olanib 50mg (Olaparib INN) is a PARP inhibitor used to treat BRCA1 or BRCA2-mutated cancers. Approved indications include: advanced ovarian, fallopian tube, and primary peritoneal cancer (first-line maintenance, recurrent maintenance, and monotherapy in platinum-sensitive relapsed disease); HER2-negative locally advanced or metastatic breast cancer with germline BRCA1/2 mutations; high-risk early-stage BRCA-mutated HER2-negative breast cancer (adjuvant); BRCA-mutated metastatic castration-resistant prostate cancer; and BRCA-mutated metastatic pancreatic adenocarcinoma (maintenance). Olaparib INN works by blocking PARP1 and PARP2 and trapping PARP-DNA complexes, inducing lethal DNA damage in BRCA-deficient cancer cells through synthetic lethality.

What is the correct dose of Olanib 50MG (Olaparib INN)?

The standard dose of Olanib is 300mg (six 50mg tablets) taken twice daily morning and evening for a total daily dose of 600mg, applicable across all approved cancer indications. The 50mg tablet strength supports clinically required dose reductions: a first reduction to 200mg (four tablets) twice daily, and a second reduction to 100mg (two tablets) twice daily if further adjustment is needed. For patients with moderate renal impairment (CrCl 31–50 mL/min), the dose is 200mg twice daily. If moderate CYP3A inhibitors cannot be avoided, the dose is reduced to 100mg twice daily. Always follow your prescribing oncologist’s exact dosing instructions.

What strength and pack size is Olanib (Olaparib INN) available in?

Olanib is available as 50mg film-coated tablets supplied in a pot of 30 tablets. The 50mg strength is taken as six tablets twice daily to achieve the standard 300mg twice-daily dose. The 30-tablet pot and the 50mg unit strength together give oncologists the full range of dose flexibility required by international clinical guidelines from the standard 300mg twice daily down to 200mg or 100mg twice daily without tablet manipulation.

Is Olanib the same as Lynparza (Olaparib by AstraZeneca)?

Yes. Olanib contains the same active ingredient as Lynparza Olaparib INN in an equivalent film-coated tablet dosage form. Olanib delivers the same PARP1 and PARP2 inhibition mechanism and synthetic lethality in BRCA-mutated tumour cells as Lynparza, at a significantly more affordable cost. This makes Olanib a financially accessible and dose-flexible long-term treatment option for oncology patients globally.

What are the side effects of Olanib 50MG (Olaparib INN)?

Common side effects of Olanib include anaemia, nausea, vomiting, fatigue, neutropenia, thrombocytopenia, leukopenia, diarrhoea, abdominal pain, headache, decreased appetite, and dysgeusia. Serious but less common risks include Myelodysplastic Syndrome (MDS), Acute Myeloid Leukaemia (AML), pneumonitis, and venous thromboembolism (VTE). Routine CBC monitoring is mandatory before and throughout treatment. Always consult your oncologist for a complete individual risk-benefit assessment before and during Olanib therapy.

Does Olanib require a BRCA test before treatment?

Yes. All patients must have a confirmed deleterious or suspected deleterious BRCA1 or BRCA2 mutation detected by an approved validated companion diagnostic test before initiating Olanib therapy. BRCA mutation testing may be performed on blood (germline testing) or tumour tissue (somatic testing) depending on the specific cancer indication. Your oncologist will arrange the appropriate biomarker test prior to prescribing Olanib.

Is Olanib (Olaparib INN) safe during pregnancy or while breastfeeding?

No. Olanib is not recommended during pregnancy or breastfeeding due to potential embryotoxic and teratogenic risks to the foetus and neonate. Female patients of childbearing potential must use highly effective contraception during the full course of Olanib treatment and for at least six months after the final dose. Male patients with female partners of childbearing potential must use effective contraception during treatment and for three months after the final dose. Consult your oncologist before starting treatment if you are pregnant, planning to become pregnant, or currently breastfeeding.

Can I order Olanib 50MG (Olaparib INN) online with worldwide shipping?

Yes. Mediaid Pharmacy supplies Olanib (Olaparib INN) 50mg to patients and healthcare providers globally with worldwide export shipping. Contact Mediaid Pharmacy via WhatsApp, phone, or WeChat at +8801773428128, or send an email enquiry to info@mediaidpharmacy.com for pricing, stock availability, regulatory documentation, and delivery details for your country.

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