Important Safety Information
Olaparib is a prescription anticancer medicine used in specific cancer treatment settings. It belongs to a class of medicines called PARP inhibitors and should be used only under the supervision of a qualified healthcare professional.
Olaparib can cause important side effects and may interact with other medicines. Before starting treatment, your doctor should review your cancer diagnosis, previous treatments, other medicines, kidney and liver function, pregnancy status, and other relevant medical factors.
The 150 mg tablet is a tablet strength. It does not necessarily mean that 150 mg is the complete dose prescribed for a patient.
Serious Blood-Related Problems
Olaparib can affect the bone marrow and reduce the production of blood cells.
This may result in:
- Anemia
- Neutropenia
- Leukopenia
- Thrombocytopenia
- Other reductions in blood-cell counts
Reduced blood-cell counts can increase the risk of tiredness, infection, bruising, or bleeding.
Your healthcare professional may perform regular blood tests during treatment to monitor blood counts.
Contact your healthcare team promptly if you develop:
- Unusual or persistent weakness
- Shortness of breath
- Fever
- Recurrent infections
- Unexplained bruising
- Unusual bleeding
- Pale skin
- Symptoms that may suggest anemia or infection
Myelodysplastic Syndrome and Acute Myeloid Leukemia
Rare but serious blood or bone-marrow disorders, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), have been reported in patients receiving olaparib.
The risk may be influenced by previous cancer treatments, including chemotherapy and radiation, and by the individual patient’s treatment history.
Tell your doctor about previous cancer treatments before starting olaparib.
If persistent or concerning abnormalities appear on blood tests, your healthcare professional may investigate further.
Pneumonitis
Olaparib has been associated with pneumonitis, an inflammatory condition affecting the lungs.
Seek medical attention if you develop new or worsening:
- Shortness of breath
- Cough
- Difficulty breathing
- Fever
- Chest discomfort
These symptoms can have many possible causes, but new respiratory symptoms during olaparib treatment should be assessed by a healthcare professional.
Pregnancy and Embryo-Fetal Toxicity
Olaparib may cause harm to an unborn baby.
Women who can become pregnant should discuss pregnancy prevention with their healthcare professional before starting treatment.
Pregnancy should be avoided during treatment according to the recommendations applicable to the prescribed product and treatment setting.
Patients who become pregnant while taking olaparib should contact their healthcare professional promptly.
Breastfeeding
Breastfeeding is generally not recommended during treatment with olaparib and for the period specified in the applicable prescribing information after the final dose.
Discuss breastfeeding with your doctor before starting treatment.
Your healthcare professional can provide advice based on the specific olaparib product, treatment regimen, and individual circumstances.
Fertility Considerations
Olaparib may have effects relevant to reproductive health.
Patients who are concerned about fertility should discuss this with their oncologist before treatment begins.
Where appropriate, fertility-preservation options may need to be considered before starting cancer therapy.
Kidney Function
Kidney function can affect olaparib exposure.
Patients with reduced kidney function should tell their healthcare professional before starting treatment.
Dose adjustment may be required for patients with moderate renal impairment.
Do not change your olaparib dose yourself based on kidney-test results.
Your doctor will determine whether a dose adjustment is necessary.
Liver Function
Tell your healthcare professional if you have liver disease or abnormal liver-function tests.
Your doctor may consider your liver function when deciding whether olaparib is appropriate and how treatment should be monitored.
Drug Interactions
Olaparib can interact with other medicines.
Some medicines can increase olaparib exposure, while others can reduce its effectiveness by changing how olaparib is metabolized.
Before starting olaparib, provide your doctor or pharmacist with a complete list of:
- Prescription medicines
- Over-the-counter medicines
- Vitamins
- Herbal products
- Nutritional supplements
- Medicines used occasionally
Do not start a new medicine or supplement without checking whether it is compatible with olaparib.
Medicines That May Affect Olaparib
Olaparib is particularly affected by medicines that influence CYP3A, an enzyme involved in its metabolism.
Strong or moderate CYP3A inhibitors can increase olaparib exposure.
Strong or moderate CYP3A inducers can decrease olaparib exposure and may reduce its effectiveness.
Examples of medicines that may require particular attention include certain:
- Antifungal medicines
- Antibiotics
- Antiepileptic medicines
- HIV medicines
- Other medicines that strongly affect CYP3A activity
This is not a complete list.
Never stop an essential medicine simply because you are taking olaparib. Ask your doctor or pharmacist to review the combination.
Avoid Grapefruit and Seville Oranges When Advised
Grapefruit and Seville oranges can affect CYP3A activity and may alter olaparib exposure.
Depending on the specific product labeling and treatment circumstances, your healthcare professional may advise avoiding grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment.
Follow the dietary instructions given by your healthcare team.
Previous Cancer Treatment
Your previous treatment history is important when assessing olaparib safety.
Tell your oncologist if you have previously received:
- Platinum-based chemotherapy
- Other chemotherapy
- Radiation therapy
- Other targeted cancer treatments
- Immunotherapy
- Previous PARP inhibitor treatment
Your doctor will consider previous treatment, response, blood counts, and other clinical factors when determining whether olaparib is appropriate.
Genetic and Biomarker Testing
Olaparib is used in specific treatment settings where cancer characteristics or inherited genetic information may be relevant.
Depending on the indication, testing may include assessment of:
- BRCA1
- BRCA2
- Homologous recombination repair or deficiency-related biomarkers
- Other cancer-specific molecular characteristics
The required testing depends on the cancer type and regulatory indication.
A positive or negative test result should always be interpreted by an appropriately qualified healthcare professional.
Do Not Use Olaparib Without Appropriate Medical Assessment
Olaparib should not be started simply because a patient has cancer or because a particular genetic mutation has been identified.
Treatment suitability depends on the complete clinical situation.
Your healthcare professional may consider:
- Cancer type
- Disease stage
- Biomarker status
- Previous treatments
- Response to previous treatment
- Blood counts
- Kidney function
- Other medical conditions
- Current medicines
- Potential benefits and risks
Monitoring During Treatment
Regular monitoring may be necessary while taking olaparib.
Depending on your circumstances, your healthcare team may monitor:
- Complete blood counts
- Kidney function
- Liver function
- Symptoms of infection
- Respiratory symptoms
- Signs of bleeding
- Symptoms of anemia
- Treatment response
- Other safety parameters
The frequency of monitoring is determined by your healthcare professional.
Symptoms That Require Prompt Medical Attention
Contact your healthcare team promptly if you experience:
- Fever or signs of infection
- Unusual bleeding or bruising
- Severe or persistent weakness
- New or worsening shortness of breath
- Persistent cough
- Chest discomfort
- Severe or persistent vomiting
- Severe diarrhea
- Symptoms of dehydration
- A significant change in your general condition
If symptoms are severe or potentially life-threatening, seek emergency medical care.
Taking Other Anticancer Medicines
Olaparib may be prescribed alone or, in specific approved treatment settings, together with another anticancer medicine.
The appropriate combination depends on the cancer type and applicable regulatory approval.
Do not combine olaparib with another anticancer treatment unless the combination has been specifically prescribed by your oncology team.
Treatment Adherence and Safety
Take olaparib exactly as prescribed.
Do not:
- Take extra tablets to compensate for a missed dose
- Change the prescribed dose
- Stop treatment without discussing it with your doctor
- Share olaparib with another person
- Use another person’s olaparib
- Crush or alter the tablets unless specifically instructed
If you miss a dose, follow the missed-dose instructions provided by your healthcare professional or the applicable product information.
Safe Storage and Handling
Keep olaparib in its original packaging and store it according to the product’s labeling instructions.
Keep the medicine away from children and other people for whom it was not prescribed.
Do not use tablets that are damaged or appear abnormal without first asking a pharmacist or healthcare professional.
Safety of Olanib 150 mg and Olakin 150 mg
The two olaparib products featured on this website are:
Olanib 150 mg — Everest Pharmaceuticals Ltd.
Olakin 150 mg — Ziska Pharmaceuticals Limited
Both contain olaparib 150 mg as the active pharmaceutical ingredient.
Product-specific labeling, packaging, storage requirements, and approved uses should be confirmed from the relevant manufacturer’s current information and applicable regulatory requirements.
Important Reminder About the 150 mg Strength
Olaparib is available in different tablet strengths.
A prescription may require more than one tablet strength or more than one tablet per dose.
Therefore, patients should never assume that taking one 150 mg tablet is the correct dose.
The prescribed dose depends on the indication and individual clinical factors.
If You Experience a Side Effect
Do not automatically stop olaparib because of a side effect.
Some adverse reactions can be managed through supportive treatment, monitoring, temporary interruption, or dose adjustment under medical supervision.
However, serious symptoms should be reported promptly.
Your oncologist will determine whether treatment should continue, be temporarily interrupted, or be modified.
Final Safety Message
Olaparib can provide an important treatment option for patients with specific cancers and molecular characteristics, but it is not suitable for everyone.
The medicine should be prescribed and monitored by an appropriately qualified healthcare professional.
Always use the current prescribing information applicable to your country and specific olaparib product.
If you have questions about your dose, other medicines, pregnancy, side effects, blood tests, or whether olaparib is appropriate for you, speak with your oncologist or pharmacist before making changes to your treatment.