Olaparib

Olaparib (Lynparza) is a PARP inhibitor used to treat types of breast cancer, prostate cancer, ovarian cancer, pancreatic cancer, fallopian tube cancer, or peritoneal cancer. Olaparib works by blocking a protein called PARP which helps cancer cells repair themselves, blocking PARP causes the cancer cells die.

Olaparib is often used if your cancer has a specific genetic marker, including BRAC1, BRCA2, HRR, and HER2-negative. Your doctor will test you for this gene.

Olaparib is a tablet that is usually taken twice daily, with or without food.

Lynparza was first FDA-approved in 2014 for advanced ovarian cancer.

Olaparib is FDA-approved to treat specific types of cancer.

BRCA-mutated Advanced Ovarian cancer

• first-line maintenance treatment,
• adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer,
• who are in complete or partial response to first-line platinum-based chemotherapy.
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

HRD-positive Advanced Ovarian Cancer

• first-line maintenance treatment in combination with bevacizumab
• adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are an incomplete or partial response to first-line platinum-based chemotherapy
• Cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

Recurrent Ovarian Cancer

• maintenance treatment
• adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Germline BRCA-mutated HER2-negative High-Risk Early Breast Cancer

• adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

Germline BRCA-mutated HER2-negative Metastatic Breast Cancer

• adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
• Patients with hormone receptor (HR)-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

Germline BRCA-mutated Metastatic Pancreatic Adenocarcinoma

• first-line maintenance treatment
• adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

BRCA-mutated Metastatic Castration-Resistant Prostate Cancer

• Used in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
• patients should be selected based on an FDA-approved companion diagnostic for this medicine.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• In adult patients who have progressed following prior treatment with enzalutamide or abiraterone.
• Patients should be selected for therapy based on an FDA-approved companion diagnostic for this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Olaparib directions

Olaparib is usually taken twice per day. Take your doses at regular intervals, about 12 hours apart. You may take olaparib with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Olaparib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

You may also need chest x-rays to be sure this medicine is not causing harmful effects on your lungs. Your cancer treatments may be delayed based on the results.

If you are taking olaparib for early breast cancer and have HR-positive disease, you should continue to take hormonal therapy. If you are taking it for prostate cancer and receiving GnRH analog therapy, continue that treatment unless you have had surgery to lower testosterone.

Store at room temperature away from moisture and heat.

Olaparib may cause serious bone marrow problems, including a type of blood cancer, that can lead to death. You may also get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, weakness, tiredness, trouble breathing, easy bruising or bleeding, blood in your urine or stools, or weight loss.

You will need weekly or monthly blood tests, and your cancer treatments may be delayed based on the results.

Some people who take olaparib with a gonadotropin-releasing hormone (GnRH) medicine may develop a blood clot in the leg or in the lung. Call your doctor if you have pain or swelling in your arm or leg, shortness of breath, chest pain, rapid breathing, or fast heartbeats.

Olaparib may also cause serious lung problems. Call your doctor if you have chest pain, wheezing, trouble breathing, or a new or worsening cough.

Olaparib may cause severe liver problems that can lead to death. Tell your doctor right away if you notice discomfort on the right side of your stomach, dark or "tea-colored" urine, or yellowing of your skin or eyes.

You should not use Olaparib if you are allergic to olaparib.

To make sure Olaparib is safe for you, tell your doctor if you have ever had:

• lung disease, breathing problems; or
• kidney disease.

Pregnancy

Olaparib can harm an unborn baby or cause a miscarriage if the mother or the father is using this medicine.

• If you are a woman, do not use this medicine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. Also do not donate sperm during the 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine

Breastfeeding

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Common olaparib side effects may include:

• low blood cell counts;
• nausea, vomiting, diarrhea;
• heartburn, indigestion, loss of appetite;
• dizziness, feeling weak or tired;
• headache;
• cough, shortness of breath; or
• altered sense of taste.

Serious olaparib side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, weakness, feeling light-headed or very tired;
• mouth sores, skin sores;
• easy bruising, unusual bleeding;
• pain or burning when you urinate, blood in your urine or stools;
• pale skin, cold hands and feet;
• weight loss; or
• cough, wheezing, shortness of breath.

Your cancer treatments may be delayed if you have certain side effects.

Some people who take olaparib with a gonadotropin-releasing hormone (GnRH) medicine may develop a blood clot in the leg or in the lung. Call your doctor if you have pain or swelling in your arm or leg, shortness of breath, chest pain, rapid breathing, or fast heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The dose is usually 300 mg orally 2 times a day. The dose may be changed by your doctor due to renal impairment or other factors.

Lynparza is available in 150 mg and 100mg tablets.

For more detailed dosing information, click on the link below.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Do not take more than 4 olaparib tablets in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with olaparib, as they may increase the level of the medicine in your blood and cause side effects.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect olaparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

• Store at room temperature, between 68°F to 77°F (20°C to 25°C).
• Store in the original bottle to protect it from moisture.
• Keep all medicines out of reach of children.

Active ingredient: olaparib

Lynparza Inactive ingredients:Tablet contains: copovidone, mannitol, colloidal silicon dioxide and sodium stearyl fumarate. Tablet coating contains: hypromellose, polyethylene glycol 400, titanium dioxide, ferric oxide yellow and ferrosoferric oxide (150 mg tablet only).

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.