niraparib

What is the most important information I should know about niraparib?

What is niraparib?

Niraparib is used as a "maintenance" treatment in adults to keep certain types of cancer from coming back. This includes cancers of the ovary, fallopian tube, or peritoneum (the membrane that lines the inside of your abdomen and covers some of your internal organs).

Niraparib is given after you have received chemotherapy (with cisplatin, oxaliplatin, carboplatin, or other similar products) and your cancer has responded to that medicine.

Niraparib is sometimes used only if your cancer has a specific genetic marker (an abnormal "BRCA" gene) or other gene mutations. Your doctor will make sure you have the correct tumor type to be treated with niraparib.

Niraparib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking niraparib?

Tell your doctor if you have or have ever had:

• an allergy or sensitivity to aspirin or tartrazine (food dye);
• heart disease;
• high blood pressure; or
• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

It may be harder for you to get a woman pregnant while you are using this medicine.

How should I take niraparib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take niraparib with or without food, but take it at the same time each day.

Take this medicine at bedtime if it upsets your stomach.

If you vomit shortly after taking niraparib, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Your blood pressure and heart rate will need to be checked often.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid while taking niraparib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of niraparib?

• pounding heartbeats or fluttering in your chest;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• pain or burning when you urinate; or
• headache, vision changes, confusion, seizure with our without pounding in your neck or ears.

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

Common side effects may include:

• stomach pain, loss of appetite, nausea, vomiting;
• constipation, diarrhea;
• abnormal blood tests;
• little or no urination, changes in the color of your urine, painful urination;
• back or muscle pain;
• headache, dizziness;
• sleep problems (insomnia);
• tiredness;
• cough, shortness of breath; or
• rash.

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.

What other drugs will affect niraparib?

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

Where can I get more information?

Your doctor or pharmacist can provide more information about niraparib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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