Romiplostim belongs to a class of medications called thrombopoiesis-stimulating proteins. Romiplostim is a medication used to treat low platelet levels for people with immune (idiopathic) thrombocytopenic purpura (ITP). ITP is a disease where the immune system is confused and attacks the platelet cells in the blood, destroying them.

Platelets are the cells in the blood that form blood clots which seal cuts and prevent bleeding. Romiplostim stimulates the bone marrow (the part of the bone that makes blood cells) to produce more platelets, which helps to prevent bleeding and bruising. Romiplostim may be used alone or in combination with other medications.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose of romiplostim is based on body weight and calculated as 1 µg per kilogram of body weight.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Romiplostim is given as an injection under the skin (subcutaneous) once weekly.

People taking romiplostim will need to have their platelet levels checked regularly. Your doctor will order blood tests to do this. The doctor may adjust the dose of romiplostim based on these test results to ensure that the proper amount of medication is being given to maintain your platelet levels.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive romiplostim, contact your doctor as soon as possible to reschedule your appointment.

This medication does not contain preservatives and must be mixed with sterile water for injection before a subcutaneous injection is given. Once the powder has been mixed, it should be used within 24 hours. The mixed powder can remain at room temperature (25°C) or can be refrigerated at 2°C to 8°C for up to 24 hours prior to injection. The mixed powder must be protected from light. It should not be shaken or agitated.

Store this medication in the refrigerator at 2°C to 8°C (do not freeze), protect it from light, and keep it out of the reach of children.

250 µg/0.5 mL
Each vial of sterile lyophilized solid white powder contains romiplostim 375 µg. Nonmedicinal ingredients: dilute hydrochloric acid (for pH adjustment), L-histidine, mannitol, polysorbate 20, and sucrose.

500 µg/1 mL
Each vial of sterile lyophilized solid white powder contains romiplostim 625 µg. Nonmedicinal ingredients: dilute hydrochloric acid (for pH adjustment), L-histidine, mannitol, polysorbate 20, and sucrose.

Do not use this medication if you:

• are allergic to romiplostim or any ingredients of this medication
• are allergic to medications made from the bacteria E. coli

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• dizziness
• fatigue
• gas
• headache
• heartburn or indigestion
• joint pain
• muscle pain or weakness
• nausea
• pain in your hands and feet
• shoulder pain
• sinusitis
• tingling or numbness of the hands or feet
• trouble sleeping
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• bronchitis (airway inflammation) (e.g., cough, wheezing, difficulty breathing)
• rash
• signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness or weakness)
• signs of bleeding (e.g., nosebleeds; blood in urine; coughing blood; bleeding gums; cuts that don’t stop bleeding; unusual bruising; bloody, black, or tarry stools; or vomiting blood or material that looks like coffee grounds)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• burning pain, redness, and warmth of the feet and hands
• if you have stopped taking romiplostim and experience any symptoms related to your ITP condition that you had before starting treatment, including bleeding
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of a blood clot (such as headache, tingling in hands or feet, swelling and redness in areas such as the calf)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: Serious bleeding can occur while taking romiplostim. Your doctor will monitor you closely by having you take regular blood and lab tests while you are taking this medication. If you stop taking romiplostim, your platelet levels may drop, which can put you at risk for serious or life-threatening bleeding. If you experience any signs or symptoms of bleeding (e.g., black and tarry stools, blood in the urine, easy bruising, cuts that won't stop bleeding), contact your doctor immediately.

Blood clots: This medication increases the amount of platelets in your blood to help prevent bleeding. This can also put you at risk of having an unwanted blood clot. If you experience any signs or symptoms of a blood clot (e.g., headache, tingling in hands or feet, swelling and redness in areas such as the calf), contact your doctor immediately.

Blood disorders: If you have blood disorders other than ITP (including blood cancers), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Bone marrow: Using romiplostim for a long period of time may cause changes in your bone marrow, which can lead your body to make abnormal blood cells or fewer blood cells. These signs of bone marrow changes show up in blood tests. Your doctor will monitor you carefully while you are taking this medication.

Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if romiplostim passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.