Nplate 250 mcg subcutaneous solution

Generic name:
Romiplostim - injection

Pronunciation
(ROE-mi-PLOE-stim)

Brand name(s)
Nplate

This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which the blood does not clot properly due to a lack of platelets. Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Romiplostim decreases your risk of bleeding by increasing the number of platelets. Romiplostim is also given to people whose ability to make platelets is reduced due to exposure to large amounts of radiation. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

Read the Medication Guide provided by your pharmacist before you start using romiplostim and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once a week. The dosage is based on your medical condition, weight, lab tests, and response to treatment.

Your risk of bleeding may increase when you stop using romiplostim. Your doctor should order weekly blood tests for at least 2 weeks after your last dose. Tell your doctor right away if you develop any bleeding/bruising.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition (bleeding/bruising) lasts or gets worse.

Headache, joint/muscle pain, dizziness, heartburn, abdominal pain, tingling/numbness in hands/feet, and trouble sleeping may occur. In children, fever, mouth/throat pain, diarrhea, easy bruising, or swelling hands/ankles/feet may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs), especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• trouble speaking
• weakness on one side of the body
• sudden vision changes
• confusion
• unusual sweating
• sudden/severe headaches

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots
• other blood disorders (such as blood cancer, myelodysplastic syndrome)
• liver disease

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: pain/swelling/warmth in the groin/calf, sudden shortness of breath, coughing up blood, sudden dizziness/fainting, chest/jaw/left arm pain, trouble speaking, weakness on one side of the body, vision problems/changes.

Lab and/or medical tests (such as blood and platelet counts) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.