Nplate

Generic Name: romiplostim (Subcutaneous route)

roe-mi-PLOE-stim

Commonly used brand name(s):

In the U.S.

• Nplate

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Thrombopoietin Receptor Agonist

Uses For Nplate

Romiplostim is used to treat low blood platelet counts (thrombocytopenia) and help prevent bleeding in patients with a blood disorder called idiopathic thrombocytopenic purpura (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) and other medicines, such as steroids or immunoglobulins, have not worked well enough.

Romiplostim is only available through a restricted access program. Doctors who are enrolled in the restricted program can write a prescription for this medicine.

Before Using Nplate

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of romiplostim in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of romiplostim in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving romiplostim.

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Bleeding problems or
• Blood cancer or
• Blood clots or
• Bone marrow problems (e.g., myelodysplastic syndrome)—Use with caution. May make these conditions worse.

Proper Use of Nplate

A doctor or other trained health professional will give you this medicine. This medicine is given as a shot under your skin.

This medicine will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Your doctor will ask you to sign a form to show that you understand this information.

Precautions While Using Nplate

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Nplate Side Effects

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:

• black, tarry stools
• bleeding gums
• blood in the urine or stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty breathing
• pain in the chest, groin, or legs, especially the calves
• pinpoint red spots on the skin
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sudden, unexplained shortness of breath
• unusual bleeding or bruising
• vision changes

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:

• Acid or sour stomach
• belching
• difficulty with moving
• dizziness
• headache
• heartburn
• indigestion
• muscle aching or cramping
• muscle pains or stiffness
• pain in the arms or legs
• pain in the joints
• pain in the shoulder
• sleeplessness
• stomach discomfort, upset, or pain
• swollen joints
• trouble sleeping
• unable to sleep

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.

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