Olaparib

Olaparib is a prescription medication used to treat women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. Olaparib kills cancer cells.

This drug is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.

This medication comes in capsule form and is taken 2 times a day. Do not chew, divide, or break olaparib capsules. Swallow the capsules whole.

Common side effects of olaparib include nausea, fatigue, vomiting, and diarrhea.

Olaparib can also cause dizziness. Do not drive or operate heavy machinery until you know how olaparib affects you.

Olaparib is a prescription medication used to treat women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Olaparib may be found in some form under the following brand names:

• Lynparza

Serious side effects have been reported with olaparib. See the “Olaparib Precautions” section.

Common side effects of olaparib include:

• nausea
• fatigue
• vomiting
• diarrhea
• distorted taste (dysgeusia)
• indigestion (dyspepsia)
• headache
• decreased appetite
• common cold-like symptoms (nasopharyngitis)
• cough
• joint paint (arthralgia)
• musculoskeletal pain
• muscle pain (myalgia)
• back pain
• rash (dermatitis)
• abdominal pain

This is not a complete list of olaparib side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amprenavir (Agenerase)
• aprepitant (Emend)
• atazanavir (Reyataz)
• boceprevir (Victrelis)
• bosentan (Tracleer)
• carbamazepine (Tegretol, Equetro, Carbatrol, Epitol)
• ciprofloxacin (Cipro, Cetraxal, Ciloxan)
• clarithromycin (Biaxin)
• crizotinib (Xalkori)
• darunavir (Prezista)
• diltiazem (cardizem, Dilt-CD)
• efavirenz (Sustiva)
• erythromycin (Ilotycin, Ery-Ped, Staticin, Ery-tab, Erythra-Derm, Pce, T-Stat, Akne-mycin, Eryc, Ery)
• etravirine (Intelence)
• fluconazole (Diflucan)
• fosamprenavir (Lexiva)
• imatinib (Gleevec)
• indinavir (Crixivan)
• itraconazole (Onmel, Sporanox)
• ketoconazole (Xolegel, Extina, Nizoral)
• lopinavir/ritinovir (Kaletra)
• modafinil (Provigil)
• nafcillin
• nefazodone (Serzone)
• nelfinavir (Viracept)
• phenytoin (Phenytek, Dilantin, Dilantin-125)
• posaconazole (Noxafil)
• rifampicin (Rifadin)
• ritonavir (Norvir)
• saquinavir (Fortovase, Invirase)
• St. John’s Wort
• telaprevir (Incivek)
• telithromycin (Ketek)
• verapamil (Calan, Covera-HS, Verelan)
• voriconazole (Vfend)

This is not a complete list of olaparib drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with olaparib, including the following:

• the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells, and acute myeloid leukemia, a bone marrow cancer. Tell your healthcare provider right away if you have some or all of the following symptoms of myelodysplastic syndrome or acute myeloid leukemia:
  • weakness
  • weight loss
  • fever
  • frequent infections
  • blood in urine or stool
  • shortness or breath
  • feeling very tired
  • bruising or bleeding more easily than normal
• lung inflammation. Tell your healthcare provider right away if you have some or all of the following symptoms of lung inflammation:
  • shortness of breath
  • fever
  • cough
  • wheezing

Olaparib can also cause dizziness. Do not drive or operate heavy machinery until you know how olaparib affects you.

Do not take olaparib if you:

• are allergic to olaparib or to any of its ingredients

Grapefruit, grapefruit juice, and Seville oranges (sometimes used in marmalade) may interact with olaparib and lead to potentially dangerous effects. Discuss the use of grapefruit products and Seville oranges with your doctor.

Before taking olaparib, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to olaparib or to any of its ingredients
• have lung or breathing problems
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Olaparib falls into category D. It has been shown that use of olaparib in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if olaparib crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using olaparib.

Take olaparib exactly as prescribed.

Olaparib comes in capsule form and is taken 2 times every day. Do not chew, divide, or break olaparib capsules. Swallow capsules whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of olaparib at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of olaparib is 400 mg twice daily.

If you take too much olaparib, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If olaparib is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store olaparib at room temperature.
• Keep this and all medications out of the reach of children.