How does this medication work? What will it do for me?
Olaparib belongs to the class of medications called antineoplastics. It is used to treat certain types of cancers of the ovaries, fallopian tubes, and peritoneum (a layer of tissue that lines the abdomen). Olaparib is also used to treat certain types of breast, pancreatic, and prostate cancers that have metastasized. Olaparib is used for people with a specific type of gene mutation called BRCA. Olaparib works by preventing cancer cells from repairing damage to their DNA. This helps to kill the cancer cells.
Olaparib has also been granted a notice of compliance with conditions (NOC/c) by Health Canada for the treatment of certain cancers of the ovaries, fallopian tubes, and peritoneum for people who do not have the BRCA gene mutation. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, opaque, hard capsule, marked in black ink with "OLAPARIB 50 mg" on the cap and the AstraZeneca logo on the body, contains 50 mg of olaparib. Nonmedicinal ingredients: gellan gum (E418), hypromellose, iron oxide black (E172), lauroyl macrogol-32 glycerides, potassium acetate, shellac, and titanium dioxide (E171).
Each yellow-to-dark-yellow, oval, biconvex tablet debossed "OP 100" on one side and plain on the reverse, contains 100 mg olaparib. Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, mannitol, and sodium stearyl fumarate; coating hypromellose, Macrogol 400, titanium dioxide (E171), and iron oxide yellow (E172)
Each green-to-green/grey, oval, biconvex tablet, debossed "OP 150" on one side and plain on the reverse, contains 100 mg olaparib. Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, mannitol, and sodium stearyl fumarate; coating hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide black (E172), and iron oxide yellow (E172)
How should I use this medication?
Olaparib is available in both a capsule and a tablet form. The capsules and tablets are not equal and the amount of drug absorbed by the body is not the same. The dosage form should only be changed when your doctor requests it.
Capsules: Olaparib capsules are approved for treatment of cancers of the ovaries, fallopian tubes, and peritoneum only. The recommended adult dose of olaparib capsules is 400 mg (8 × 50 mg capsules) taken by mouth, 2 times a day. Depending on side effects of the medication, your doctor may reduce the dose that you take.
Olaparib capsules should be swallowed whole with water. Do not chew, crush, dissolve, or otherwise divide the capsules to take them. Take this medication on an empty stomach at least 1 hour after a meal. Do not eat for 2 hours after taking this medication. Do not drink grapefruit juice while you are taking this medication.
Tablets: Olaparib tablets are approved for treatment of cancers of the ovaries, fallopian tubes, and peritoneum, certain types of breast cancer, and pancreatic cancer and prostate cancer.
The recommended adult dose of olaparib tablets is 300 mg (2 × 150 mg tablets) taken by mouth, 2 times a day. Depending on the side effects of the medication, your doctor may reduce the dose that you take.
Swallow the tablets whole with water. Do not chew, crush, dissolve, or otherwise divide them. This medication may be taken with food or on an empty stomach. Do not drink grapefruit juice while you are taking this medication.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, in its original container, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to olaparib or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- changed sense of taste
- loss of appetite
- mouth sores
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- itchy rash on swollen, red skin
- severe diarrhea
- shortness of breath
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of bladder inflammation (e.g., increased need to urine; cloudy, dark or strong smelling urine; pain or discomfort when urinating; blood in the urine)
- signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of lung inflammation (e.g., new or worsening shortness of breath, cough, fever)
- signs of lung infection (pneumonia; cough that may produce phlegm, fever, chills, shortness of breath)
- stomach pain (under the ribs)
- symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of a blood clot in the lung (e.g., difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Anemia: Olaparib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Birth control: The effectiveness of hormonal birth control (birth control pill or monthly injections) may be reduced by olaparib. Additional forms of birth control are recommended while taking olaparib and for at least 1 month after stopping the medication.
Bleeding: This medication may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.
Drowsiness/dizziness: Olaparib may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.
Grapefruit and grapefruit juice: Grapefruit, star fruit, pomegranate, Seville oranges, and their juices interfere with how this medication is broken down and removed from the body. Consuming any of these products while taking olaparib may cause the medication to build up in the body, causing severe side effects. For this reason, you should avoid these fruits and their juices while taking olaparib.
Infection: As well as killing cancer cells, olaparib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.
Kidney function: Decreased kidney function may cause this medication to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Olaparib is not recommended for people with severe kidney impairment or end-stage renal disease.
Liver function: Decreased liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lung inflammation: On rare occasions, some people taking this medication have experienced lung inflammation (pneumonitis) causing difficulty breathing. This can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking olaparib, contact your doctor immediately.
Other cancers: Rarely, people who are using olaparib develop myelodysplastic syndrome/acute myeloid leukemia (AML) or other diseases where the bone marrow is not able to properly make blood cells. These illnesses can be life-threatening. Discuss any concerns you may have with your doctor.
Pregnancy: The safety of this medication when used by a woman during pregnancy has not been studied. Due to the potential for harm to the developing baby, olaparib should not be used during pregnancy. If you or your partner becomes pregnant while taking this medication, contact your doctor immediately.
Women who may become pregnant must use effective contraception while taking this medication and for 1 month after the last dose of olaparib. Male patients with partners who may become pregnant should use effective contraception while taking this medication and for 3 months after the last dose of olaparib.
Breast-feeding: It is not known if olaparib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Do not breast-feed while you are taking olaparib and for at least 1 month after taking the last dose of this medication.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between olaparib and any of the following:
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- bacillus Calmette-Guérin (BCG)
- certain protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, idelalisib, imatinib, nilotinib, palbociclib)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- lumacaftor and ivacaftor
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- St. John's wort
- "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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