Romiplostim

Generic Name: romiplostim (ROM i PLOS tim)Brand Names: Nplate

What is romiplostim?

Romiplostim is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Romiplostim is usually given after other medications have been tried without successful treatment of symptoms.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

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

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

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Before you use romiplostim, tell your doctor if you have kidney or liver disease.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

What should I discuss with my health care provider before receiving romiplostim?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use romiplostim, tell your doctor if you have kidney or liver disease.

FDA pregnancy category C. It is not known whether romiplostim is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while receiving romiplostim. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether romiplostim had any effect on the baby

It is not known whether romiplostim passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Using romiplostim may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

How is romiplostim given?

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is given as an injection under the skin, usually once per week. Your doctor, nurse, or other healthcare provider will give you this injection.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. For best results, keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your romiplostim injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose can cause signs of a blood clot, including sudden numbness or weakness, sudden headache or confusion, problems with vision or speech, loss of balance, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, and pain or swelling in one or both legs.

What should I avoid while receiving romiplostim?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using romiplostim.

Romiplostim side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;

  • dizziness;

  • joint or muscle pain;

  • pain in your arms, legs, or shoulder;

  • numbness or tingly feeling;

  • sleep problems (insomnia); or

  • stomach pain or upset.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Romiplostim Dosing Information

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

Initial dose: 1 mcg/kg subcutaneous injection based on actual body weight.Use the lowest dose of romiplostim to achieve and maintain a platelet count greater than or equal to 50 x 10^9/L as necessary to reduce the risk for bleeding. Administer romiplostim as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. Romiplostim should not be used in an attempt to normalize platelet counts.

What other drugs will affect romiplostim?

There may be other drugs that can interact with romiplostim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about romiplostim.
  • 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.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:46:30 PM.
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