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 immune thrombocytopenia (ITP). This medicine is used after a splenectomy (surgery to remove the spleen) or when other medicines (eg, steroids or immunoglobulins) have not worked well enough in patients with ITP for at least 6 months. Platelets help clot the blood. Romiplostim works by stimulating the bone marrow to produce more platelets.

Romiplostim injection is also used to treat acute radiation syndrome in patients who have been exposed to high levels (myelosuppressive doses) of radiation. Myelosuppression is a bone marrow problem that can lead to a decrease in blood cell counts.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of romiplostim injection in children 1 year of age and older with ITP for at least 6 months. However, safety and efficacy have not been established in children younger than 1 year of age with ITP.

Appropriate studies on the relationship of age to the effects of romiplostim injection have not been performed in newborns with acute radiation syndrome. However, pediatric-specific problems that would limit the usefulness of this medicine are not expected.

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.

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), chronic—Use with caution. May increase risk for more serious problems.

• Thrombocytopenia caused by myelodysplastic syndrome (MDS) or conditions other than ITP—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 in a medical facility. It is given as a shot under your skin once a week for patients with ITP or once for every exposure to high levels of radiation.

This medicine comes 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 or your child's progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

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.

If you receive this medicine and you have a bone marrow problem called myelodysplastic syndromes (MDS), it may worsen and become an acute leukemia (white blood cell cancer).Talk to your doctor if you have concerns about this.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech.

Portal vein thrombosis (a blood clotting problem in the liver) may occur in patients receiving this medicine, usually in those who have low platelet counts caused by chronic liver disease (eg, cirrhosis). Check with your doctor right away if you have blood in the stool, fever, low back pain, stomach pain, yellow skin or eyes, or if you are vomiting blood.

Your condition can cause you to bleed too much when injured. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.

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:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

change in hearing

chills

cough

diarrhea

difficulty breathing

ear congestion, drainage, or pain

fever

headache

loss of appetite

loss of voice

nausea

pain or tenderness around the eyes and cheekbones

rapid weight gain

sneezing

sore throat

stomach pain

stuffy or runny nose

tightness of the chest

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

upper stomach pain

Incidence not known

Burning pain, warmth, swelling, or redness of the hands and feet

fast heartbeat

feeling of warmth

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

redness of the skin

trouble swallowing

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

bruise

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty with moving

dizziness

heartburn

indigestion

mouth or throat pain

muscle pains, cramps, or stiffness

pain in the shoulder, arms, or legs

stomach discomfort, upset, or pain

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.