Pronunciation:

oh-LAP-a-rib

Brand Names:

• Lynparza

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

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. Your doctor will test for the presence of this gene. It is used in patients who have received complete or partial treatment with platinum-based cancer medicines.

Olaparib is used together with bevacizumab as maintenance treatment in patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive tumor test for genomic instability called HRD. Your doctor will test for the presence of this gene. It is used in patients who have received complete or partial treatment with platinum-based cancer medicines.

Olaparib is also used to treat ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene that has come back. Your doctor will test for the presence of this gene. It is used in patients who have received complete or partial treatment with platinum-based cancer medicines.

Olaparib is also used to treat HER2-negative early breast cancer in patients who have been treated with other cancer medicines. It is used if the cancer cells have the germline BRCA mutations. Your doctor will use a special test to look for these mutations. It is given to patients after surgery to remove the tumor.

Olaparib is also used to treat HER2-negative metastatic (cancer that has spread) breast cancer in patients who have been treated with other cancer medicines. 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 as maintenance treatment in patients with metastatic (cancer that has spread) pancreas cancer with a certain type of inherited (germline) abnormal BRCA gene, whose disease has not progressed and who have been treated with platinum-based cancer medicines for at least 16 weeks.

Olaparib is also used to treat metastatic castration-resistant prostate cancer (prostate cancer that has spread and is resistant to medical or surgical treatments that lower testosterone) in patients who have been treated with other cancer medicines (eg, abiraterone, enzalutamide). It is used if the cancer cells have a certain type of inherited (germline) or acquired (somatic) abnormal HRR gene. Your doctor will test for the presence of this gene.

Olaparib is used in combination with abiraterone and prednisone or prednisolone to treat metastatic castration-resistant prostate cancer (prostate cancer that has spread and is resistant to medical or surgical treatments that lower testosterone) with a certain type of inherited or acquired abnormal BRCA gene. Your doctor will test for the presence of this gene.

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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.

• 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
• Tocilizumab
• 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), history of or
• Lung or breathing problems (eg, pneumonitis)—Use with caution. May make these conditions worse.

• Kidney disease, moderate—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

If you have hormone receptor positive early breast cancer, you should continue taking hormone medicines during treatment with Lynparza® tablets.

Your doctor may also give you other medicines (eg, gonadotropin-releasing hormone medicine) during prostate cancer treatment with Lynparza® tablets or you should have had surgical removal of the testes before using this medicine.

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 (tablets):
  • For ovarian cancer, fallopian tube cancer, pancreas cancer, primary peritoneal cancer, prostate cancer, or metastatic breast 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 early breast cancer:
    • Adults—300 milligrams (mg) (two 150 mg tablets) 2 times a day for up to 1 year. 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 While Using This Medicine:

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, including 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.

This medicine may increase your risk for having blood clots (eg, venous thrombosis, pulmonary embolism). Call your doctor right away if you have chest pain, fast, pounding, or irregular heartbeat or pulse, pain or swelling in the arms or legs, or rapid shallow or trouble breathing.

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 of This Medicine:

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

Black, tarry stools

bladder pain

bleeding gums

bloody or cloudy urine

body aches or pain

chest pain or tightness

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

ear congestion or pain

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

general feeling of discomfort or illness

head congestion

headache

hoarseness or other voice changes

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nausea

pain or swelling in the arms or legs

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid shallow breathing

runny or stuffy nose

shivering

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swollen glands

trouble sleeping

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Incidence not known

Hives, itching, skin rash

irritation

joint stiffness or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

trouble 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

Back pain

belching

blistering, crusting, irritation, itching, or reddening of the skin

blurred vision

burning, numbness, tingling, or painful sensations

constipation

cracked, dry, or scaly skin

decreased appetite

diarrhea

difficulty with moving

dizziness

dry mouth

fear or nervousness

flushed, dry skin

fruit-like breath odor

heartburn

increased hunger

increased thirst

increased urination

indigestion

lack or loss of strength

loss of bladder control

loss of or change in taste

muscle stiffness

stomach discomfort, upset, or pain

swelling or inflammation of the mouth

unexplained weight loss

unsteadiness or awkwardness

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.