Generic Name: Romiplostim

Romiplostim is the generic name for the trade name drug Nplate. In some cases, health care professionals may use the trade name Nplate when referring to the generic drug name Romiplostim.

Drug Type:

Nplate is a biologic response modifier.  It is classified as a colony stimulating factor.  (For more detail, see "How this drug works" section below).

What Nplate Is Used For:

• Nplate is used for the treatment of thrombocytopenia (low platelets) in patients with chronic immune (idiopathic) thrombocytopenia purpura (ITP) who have had insufficient response to corticosteroids, immune globulin, or splenectomy.
• Nplate is not indicated to normalize platelet counts.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful. However, Nplate is administered through the NEXUS program, which requires monitoring of the efficacy and use of Nplate on a periodic basis. NEXUS will also determine if the cost of Nplate is covered by insurers, and it may not be for uses outside of the approved indication (ITP)

How Nplate Is Given:

• Nplate may be given by subcutaneous (the layer between the skin and muscle) injection.
• The amount of Nplate that you will receive depends on many factors, including your height and weight, and your general health or other health problems. Your doctor will determine your exact dosage and schedule.

Side Effects:

Important things to remember about the side effects of Nplate:

• Most people do not experience the side effects listed.
• Side effects are often predictable in terms of their onset, duration, and severity.
• Side effects are almost always reversible and will go away after therapy is complete.
• There are many options to minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
• Many of the side effects observed in patients taking Nplate occurred at a rate similar to patients taking placebo.

The following side effects are common (occurring in greater than 30%) for patients taking Nplate:

• Headache
• fatigue
• Coughing up blood

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Nplate:

• Joint pain (arthralgia)
• Dizziness
• Insomnia
• Muscle pain (myalgia)
• Pain in extremity
• Abdominal pain 
• Nausea
• Upper respiratory infection

Another side effect that is uncommon, and likely occurs in less than 10% of patients treated with Nplate is bone marrow fibrosis. This involves the deposition of scar-type tissue called reticulin in the bone marrow. Your doctor should monitor you for this potential complication by looking at your blood under the microscope periodically. If specific changes occur in the blood, or if you lose your responsiveness to Nplate, a bone marrow biopsy may be needed to evaluate for reticulin fibrosis. All cases of reticulin fibrosis have been reversed or stabilized upon discontinuation of the drug, and no progressive instances of bone marrow fibrosis have been seen.

 

In patients with hematologic malignancies, there is a theoretical risk that the use of Nplate could speed the progression of the underlying disease, though this is unproven at present.

 

You should always inform your health care provider if you experience any unusual symptoms.

 

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
• Shortness of breath
• Bleeding that does not stop after applying pressure for a few minutes

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Pain or burning with urination
• Extreme fatigue (unable to carry on self-care activities)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Nplate treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Nplate.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.  Pregnancy category C (use in pregnancy only when benefit to mother outweighs risk to fetus.
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking Nplate. Barrier methods of contraception, such as condoms, are recommended.  Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Nplate.

Self-Care Tips:

• You may experience joint or muscle pain as a result of this medication.  Ask your healthcare provider if you may take a mild pain medicine to relieve this.  Acetaminophen (Tylenol) may help.
• Ask your doctor before engaging in contact sports or activities that could cause injury.
• If you experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking Nplate, to monitor side effects and check your response to therapy. Regular blood work will be obtained to monitor your complete blood count (CBC).  Periodic blood work may be done to assess the function of other organs (such as your kidneys and liver).

How Nplate Works:

Colony-Stimulating Factors:
In the body's bone marrow (the soft, sponge-like material found inside bones) blood cells are produced.  There are three major types of blood cells; white blood cells, which fight infection; red blood cells, which carry oxygen to and remove waste products from organs and tissues; and platelets, which enable the blood to clot.  Colony-stimulating factors are substances that stimulate the production of blood cells and promote their ability to function.  

Nplate is a growth factor that stimulates platelet production via the thrombopoietin receptor. 

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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