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Romiplostim (Subcutaneous route)

Pronunciation:

roe-mi-PLOE-stim

Brand Names:

  • Nplate

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Thrombopoietin Receptor Agonist

Uses of This Medicine:

Romiplostim injection is used to treat low blood platelet counts (thrombocytopenia) and help prevent bleeding in patients with a blood disorder called chronic immune thrombocytopenia (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) or when other medicines, such as steroids or immunoglobulins, have not worked well enough. Platelets help clot the blood, so a person with thrombocytopenia may have bleeding problems. Romiplostim works by stimulating the bone marrow to produce more platelets.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Other 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.

Other interactions—

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 history of or
  • Bone marrow problems (eg, myelodysplastic syndrome or MDS)—Use with caution. May make these conditions worse.
  • Liver disease (including cirrhosis)—Use with caution. May increase risk for more serious problems.
  • Thrombocytopenia caused by myelodysplastic syndrome (MDS)—Should not be used in patients with this condition.

Proper Use of This Medicine:

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

This medicine will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

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

Blood clotting problems may occur while you are receiving this medicine. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or shortness of breath and pain in your chest.

Do not stop receiving this medicine without checking first with your doctor. Stopping this medicine suddenly may cause the number of platelets to go below the number you had before you started receiving the medicine. This will increase your risk for bleeding. Your doctor will check your platelet levels and progress when you stop receiving the medicine.

Portal vein thrombosis (a blood clotting problem) occurs in patients receiving this medicine. It usually occurs in patients with low platelet counts caused by liver problems (including cirrhosis). Check with your doctor right away if you have abdominal or stomach pain, blood in the stool, or if you are vomiting blood.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

Rare
Black, tarry stools
bleeding gums
blood in the urine or stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
difficulty with 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:

More common
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
stomach discomfort, upset, or pain
swollen joints
trouble sleeping

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.


Last Updated: 4/4/2014

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