Lynparza (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). Lynparza (Olaparib) is also used to treat certain types of breast, pancreatic, and prostate cancers that have metastasized. Lynparza (Olaparib) is used for people with a specific type of gene mutation called BRCA. Lynparza (Olaparib) works by preventing cancer cells from repairing damage to their DNA. This helps to kill the cancer cells.

Lynparza (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 Lynparza (Olaparib) 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.

Lynparza (Olaparib) may be available under multiple brand names and/or in several different forms. Any specific brand name of Lynparza (Olaparib) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Lynparza (Olaparib) may not be used for all of the conditions discussed here.

Your doctor may have suggested Lynparza (Olaparib) 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 Lynparza (Olaparib), speak to your doctor. Do not stop taking Lynparza (Olaparib) without consulting your doctor.

Do not give Lynparza (Olaparib) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Lynparza (Olaparib) if their doctor has not prescribed it.

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Lynparza (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: Lynparza (Olaparib) capsules are approved for treatment of cancers of the ovaries, fallopian tubes, and peritoneum only. The recommended adult dose of Lynparza (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.

Lynparza (Olaparib) capsules should be swallowed whole with water. Do not chew, crush, dissolve, or otherwise divide the capsules to take them. Take Lynparza (Olaparib) on an empty stomach at least 1 hour after a meal. Do not eat for 2 hours after taking Lynparza (Olaparib). Do not drink grapefruit juice while you are taking Lynparza (Olaparib).

Tablets: Lynparza (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 Lynparza (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. Lynparza (Olaparib) may be taken with food or on an empty stomach. Do not drink grapefruit juice while you are taking Lynparza (Olaparib).

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 Lynparza (Olaparib) 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 Lynparza (Olaparib) 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.

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 Lynparza (Olaparib). If you are concerned about side effects, discuss the risks and benefits of Lynparza (Olaparib) with your doctor.

The following side effects have been reported by at least 1% of people taking Lynparza (Olaparib). 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
• Constipation
• cough
• Diarrhea
• dizziness
• headache
• heartburn
• loss of appetite
• mouth sores
• nausea
• rash
• tiredness
• vomiting
• weakness

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:

• Fever
• 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 Lynparza (Olaparib).

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Capsule

50 mg
Each white, opaque, hard capsule, marked in black ink with "Lynparza (Olaparib) 50 mg" on the cap and the AstraZeneca logo on the body, contains 50 mg of Lynparza (Olaparib). Nonmedicinal ingredients: gellan gum (E418), hypromellose, iron oxide black (E172), lauroyl macrogol-32 glycerides, potassium acetate, shellac, and titanium dioxide (E171).

Tablet

100 mg
Each yellow-to-dark-yellow, oval, biconvex tablet debossed "OP 100" on one side and plain on the reverse, contains 100 mg Lynparza (Olaparib). Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, mannitol, and sodium stearyl fumarate; coating hypromellose, Macrogol 400, titanium dioxide (E171), and iron oxide yellow (E172)

150 mg
Each green-to-green/grey, oval, biconvex tablet, debossed "OP 150" on one side and plain on the reverse, contains 100 mg Lynparza (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)

Do not take Lynparza (Olaparib) if you are allergic to Lynparza (Olaparib) or any ingredients of the medication.

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There may be an interaction between Lynparza (Olaparib) and any of the following:

• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• bacillus Calmette-Guérin (BCG)
• Bosentan
• Bupropion
• Carbamazepine
• certain protein kinase inhibitors (e.g., Ceritinib, Crizotinib, Dabrafenib, Idelalisib, imatinib, Nilotinib, Palbociclib)
• Cladribine
• Clozapine
• Cobicistat
• conivaptan
• Deferasirox
• Deferiprone
• Diltiazem
• Dronedarone
• Elagolix
• Eslicarbazepine
• Enzalutamide
• Fentanyl
• Furosemide
• 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)
• Mesalamine
• Metformin
• Methotrexate
• midazolam
• mifepristone
• Mitotane
• Modafinil
• Phenobarbital
• Phenytoin
• Pimozide
• primidone
• Quetiapine
• Repaglinide
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• siltuximab
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• Tocilizumab
• Valsartan
• Verapamil

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 Lynparza (Olaparib). 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.

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 Lynparza (Olaparib).

Anemia: Lynparza (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 Lynparza (Olaparib). Additional forms of birth control are recommended while taking Lynparza (Olaparib) and for at least 1 month after stopping the medication.

Bleeding: Lynparza (Olaparib) 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: Lynparza (Olaparib) 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 Lynparza (Olaparib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lynparza (Olaparib), 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: Lynparza (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 Lynparza (Olaparib) affects you.

Grapefruit and grapefruit juice: Grapefruit, star fruit, pomegranate, Seville oranges, and their juices interfere with how Lynparza (Olaparib) is broken down and removed from the body. Consuming any of these products while taking Lynparza (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 Lynparza (Olaparib).

Infection: As well as killing cancer cells, Lynparza (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 Lynparza (Olaparib) to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how Lynparza (Olaparib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lynparza (Olaparib), and whether any special monitoring is needed. Lynparza (Olaparib) is not recommended for people with severe kidney impairment or end-stage renal disease.

Liver function: Decreased liver function may cause Lynparza (Olaparib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Lynparza (Olaparib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lynparza (Olaparib), and whether any special monitoring is needed.

Lung inflammation: On rare occasions, some people taking Lynparza (Olaparib) 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 Lynparza (Olaparib), contact your doctor immediately.

Other cancers: Rarely, people who are using Lynparza (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 Lynparza (Olaparib) when used by a woman during pregnancy has not been studied. Due to the potential for harm to the developing baby, Lynparza (Olaparib) should not be used during pregnancy. If you or your partner becomes pregnant while taking Lynparza (Olaparib), contact your doctor immediately.

Women who may become pregnant must use effective contraception while taking Lynparza (Olaparib) and for 1 month after the last dose of Lynparza (Olaparib). Male patients with partners who may become pregnant should use effective contraception while taking Lynparza (Olaparib) and for 3 months after the last dose of Lynparza (Olaparib).

Breast-feeding: It is not known if Lynparza (Olaparib) passes into breast milk. If you are a breast-feeding mother and are taking Lynparza (Olaparib), it may affect your baby. Do not breast-feed while you are taking Lynparza (Olaparib) and for at least 1 month after taking the last dose of Lynparza (Olaparib).

Children: The safety and effectiveness of using Lynparza (Olaparib) have not been established for children.

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