Romiplostim Subcutaneous

Name: Romiplostim Subcutaneous

Commonly used brand name(s)

In the U.S.

  • Nplate

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Thrombopoietin Receptor Agonist

Before Using romiplostim

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 romiplostim, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to romiplostim 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 injection 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 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 Category Explanation
All Trimesters C Animal 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.

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 romiplostim. 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.

Uses

This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which the blood does not clot properly due to a lack of platelets. Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Romiplostim decreases your risk of bleeding by increasing the number of platelets. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

How to use Romiplostim Solution, Reconstituted (Recon Soln)

Read the Medication Guide provided by your pharmacist before you start using romiplostim and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is injected under the skin by a health care professional, usually once a week.

Dosage is based on your medical condition, weight, and response to treatment. Your doctor will order blood tests (platelet counts) to find the right dose for you. Be sure to keep all medical/lab appointments.

Your risk of bleeding may increase when you stop using romiplostim. Your doctor should order weekly blood tests for at least 2 weeks after your last dose. Tell your doctor right away if you develop any bleeding/bruising.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition (bleeding/bruising) persists or worsens.

Side Effects

Headache, joint/muscle pain, dizziness, heartburn, abdominal pain, tingling/numbness in hands/feet, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious problems from blood clots to the heart, brain or lung (such as pulmonary embolism, stroke, heart attack), especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you experience: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, weakness on one side of the body, vision problems/changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Romiplostim Solution, Reconstituted (Recon Soln) side effects by likelihood and severity.

Precautions

Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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