Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Lynparza

Descriptions


Olaparib is used as maintenance treatment in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene, who have been treated with platinum-based cancer medicines. Your doctor will test for the presence of this gene.

Olaparib is also used to treat advanced ovarian cancer in patients who have received three or more previous lines of cancer treatment. It is used if the cancer cells have the germline BRCA mutations. Your doctor will use a special test to look for these mutations.

Olaparib is also used to treat ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back. It is used in patients who have received complete or partial treatment with platinum-based cancer medicines. It is also used to treat HER2-negative metastatic (cancer that has spread) breast cancer in patients who have been treated with other cancer medicines. Olaparib belongs to the group of medicines called antineoplastics (cancer medicines).

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of olaparib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olaparib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Boceprevir
  • Bosentan
  • Carbamazepine
  • Ceritinib
  • Ciprofloxacin
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Diltiazem
  • Dronedarone
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Etravirine
  • Fluconazole
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Letermovir
  • Lopinavir
  • Lumacaftor
  • Miconazole
  • Mifepristone
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Ticagrelor
  • Tipranavir
  • Verapamil
  • Voriconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Bitter Orange
  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) or
  • Lung or breathing problems—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not substitute the two dosage forms of this medicine. Lynparza® capsules and tablets are not the same and they contain different doses.

Swallow the capsules and tablets whole. Do not crush, break, chew, open, or dissolve them. Do not take the capsules if they look damaged or have a leakage.

You may take this medicine with or without food.

Do not eat grapefruit or Seville oranges, or drink grapefruit or Seville orange juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For advanced ovarian cancer:
      • Adults—400 milligrams (mg) (eight 50 mg capsules) 2 times a day. Each dose should be taken 12 hours apart. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For breast cancer, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:
      • Adults—300 milligrams (mg) (two 150 mg tablets) 2 times a day. Each dose should be taken 12 hours apart. Your doctor may adjust your dose as needed or tolerated. However, dose is usually not more than 600 mg (four 150 mg tablets) per day.
      • Children—Use and dose must be determined by your doctor.
    • For maintenance treatment of advanced ovarian cancer:
      • Adults—300 milligrams (mg) (two 150 mg tablets) 2 times a day for up to 2 years. Each dose should be taken 12 hours apart. Your doctor may adjust your dose as needed or tolerated. However, dose is usually not more than 600 mg (four 150 mg tablets) per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the tablets in their original container.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. The tablet form may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not donate sperm while you are using the tablet form of this medicine and for 3 months after your last dose.

This medicine may cause bone marrow problems, such as myelodysplastic syndrome or acute myeloid leukemia. Check with your doctor right away if you have a fever, blood in the urine or stool, chills, unusual bleeding, bruising, tiredness, or weakness, or weight loss.

Tell your doctor right away if you have a chest pain, cough, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bladder pain
  3. bleeding gums
  4. bloody or cloudy urine
  5. body aches or pain
  6. chest pain
  7. chills
  8. cough
  9. cough producing mucus
  10. diarrhea
  11. difficult, burning, or painful urination
  12. difficulty breathing
  13. ear congestion or pain
  14. fever
  15. frequent urge to urinate
  16. general feeling of discomfort or illness
  17. head congestion
  18. headache
  19. hoarseness or other voice changes
  20. joint pain
  21. loss of appetite
  22. loss of voice
  23. lower back or side pain
  24. muscle aches and pains
  25. nasal congestion
  26. nausea
  27. painful or difficult urination
  28. pale skin
  29. pinpoint red spots on the skin
  30. runny nose
  31. shivering
  32. sneezing
  33. sore throat
  34. sores, ulcers, or white spots on the lips or in the mouth
  35. sweating
  36. swollen glands
  37. tightness in the chest
  38. trouble sleeping
  39. troubled breathing with exertion
  40. unusual bleeding or bruising
  41. unusual tiredness or weakness
  42. vomiting

Incidence not known

  1. Fast heartbeat
  2. hives, itching, skin rash
  3. irritation
  4. joint stiffness or swelling
  5. redness of the skin
  6. swelling of the eyelids, face, lips, hands, or feet
  7. troubled swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Back pain
  2. belching
  3. blistering, crusting, irritation, itching, or reddening of the skin
  4. blurred vision
  5. burning, numbness, tingling, or painful sensations
  6. constipation
  7. cracked, dry, or scaly skin
  8. decreased appetite
  9. diarrhea
  10. difficulty with moving
  11. dizziness
  12. dry mouth
  13. fear or nervousness
  14. flushed, dry skin
  15. fruit-like breath odor
  16. heartburn
  17. increased hunger
  18. increased thirst
  19. increased urination
  20. indigestion
  21. lack or loss of strength
  22. loss of bladder control
  23. loss of or change in taste
  24. muscle stiffness
  25. pain in the joints
  26. stomach discomfort, upset, or pain
  27. swelling or inflammation of the mouth
  28. unexplained weight loss
  29. unsteadiness or awkwardness
  30. weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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