Romiplostim (subcutaneous route)

Romiplostim stimulates the bone marrow to produce more platelets, helping blood to clot and prevent harmful bleeding.

Overview

Romiplostim works by increasing the number of platelets, which helps the body’s blood clotting function and reduces the risk of excessive bleeding. It also treats a chronic condition known as ITP, which makes an individual susceptible to serious bruising and continuous bleeding, caused by low platelets.

The condition of internal bleeding can range from mild to severe, depending on its cause. This treatment is reserved for individuals who cannot be treated with other medicines or have used other medicines with no success. It is not used to restore platelets to a normal level, but to aid the body during an event.

Romiplostim belongs to a class of medicines called thrombopoietin receptor agonists, prompting the bone marrow cells to produce more platelets. It’s administered by subcutaneous injection – into the fatty tissue just below the skin's surface to avoid hitting a muscle, bone or other blood vessels.

This medication is a synthesized protein instigating the production of platelets. It is not a cure for ITP and some individuals may have allergic reactions. Because it works with bone marrow cells, if you have a bone marrow disorder, you need to talk with your doctor before using this medicine. Other conditions related to blood disorders or liver disease may also affect your response to this treatment.

Conditions Treated

  • Low platelet levels
  • Chronic immune thrombocytopenic

Type of Medicine

  • Thrombopoietin receptor agonists

Side Effects

Romiplostim causes the body to produce platelets and, depending on your health condition and the disorder treated with this medicine, you may experience some unwanted side effects. These range from more common to common to rare, and not all need medical attention, but if the effect persists or worsens, you need to contact your doctor.

In most cases, the effect fades as your body accepts treatment and eases or stops the unwelcome responses. Always talk with your doctor – there are solutions available to help prevent or relieve these effects while you’re under treatment.

More common:

  • Belching
  • Cramps
  • Difficulty moving
  • Headache
  • Heartburn
  • Indigestion
  • Insomnia
  • Stiffness

Common:

  • Body pain
  • Coughing up blood
  • Excessive sweating
  • Fainting
  • Fast heartbeat
  • Lightheadedness
  • Nausea
  • Rapid breathing
  • Swelling

Rare:

  • Bleeding gums
  • Bloody urine or stools
  • Bruising
  • Continuous bleeding
  • Loss of movement
  • Slurred speech
  • Vision changes

It’s rare, but this condition can lead to bleeding in the brain. If you experience severe headaches or other neurological problems, tell your doctor. There may be other effects not listed as your own composition, age and seriousness of this condition may change the medications’ effect and trigger side effects unique to you. Do not take the seriousness of these side effects lightly; doing so can have harmful consequences to your health.

Dosage

Your doctor determines the dose according to your health when administering romiplostim subcutaneous injections. The medicine is given once a week to treat the prescribed condition. Your doctor will start with the lowest dose and monitor your response. The purpose is to maintain a platelet count that works with the condition and reduces the risk of uncontrolled bleeding. These are averages - your doctor may adjust dosage, depending on your body's response.

There’s a medication guide to using this medicine – your doctor can explain what to expect as you go through treatment. If you have any questions, ask. Remember, this is about your health and you need to know the precautions necessary to retain it.

The unit of measure for dosing uses the metric system representing micrograms, which is equivalent to a millionth of a gram or a thousandth of a milligram (mcg). It’s the smallest unit of measure used for this treatment.

For thrombocytopenia

Adult

  • Starting dose - 1 mcg/kg per week
  • Maintenance - increase or reduce the dose by 1 mcg/kg per week according to platelets during a two week treatment. Your doctor may discontinue use with no signs of improvement over a four week period.
  • Maximum not to exceed - 10 mcg/kg a week

Children

  • Pediatric - less than 18 years of age, safety and efficacy has not been established

Romiplostim is effective in treating ITP, with over 80% of patients achieving a platelet response after a few weeks of treatment. More studies are needed to observe the change in dosage for managing elevated or stable platelet counts, since other biological factors can affect individual responses.

Missed dose

Since your doctor or a medical professional administers this medicine, if you miss a dose, contact your doctor immediately to reschedule.

Interactions

Some medicines should not be used together at all, because the interactions can be harmful to your health or trigger other health ailments. Sometimes, two different medicines do work well together when managing a health condition. Your doctor may adjust the dosage of one or both medicines to keep both conditions under control.

Over the counter medicines, health supplements, herbal remedies, alcohol and tobacco can also cause serious life-threatening complications. Certain foods can have adverse reactions to drugs, prescription or nonprescription. It’s critical to let your doctor know about all the medications you are taking now and include information about your diet and lifestyle routines.

If you have a history of these medical problems and are taking medication to manage these disorders, talk with your doctor before taking this treatment. These conditions could worsen and will change romiplostim treatment outcomes:

  • Bleeding problems
  • Blood cancer
  • Blot clots
  • Bone marrow
  • Hepatic impairment
  • Leukemia
  • Liver disease
  • Renal impairment

Warnings

If you suffer from any of these existing health conditions, be sure to share as much information about your own health, current medications and your family history with the doctor. An underlying condition could be the cause.

Romiplostim injections will cause bone marrow changes which may lead to abnormal blood cells or reduce the production of blood cells. Injections can also cause platelet levels to rise beyond normal production, increasing the risk of developing a blood clot. The response can spread to the lungs, instigating a heart attack or stroke.

Your doctor will ask for regular lab tests to watch your body's response to this treatment. Once treatment has been completed, platelet levels may drop, causing the potential of excessive bleeding coupled with serious side effects for you. If you experience unusual bruising or bleeding after treatment, contact your doctor at once.

Before starting any form of medical treatment, you need to talk with the doctor to understand the risks and complications associated with receiving romiplostim injections. If you are taking prescription or non-prescription medications, they can change your body’s response to this medicine.

Allergic reactions can be serious, including breathing problems, slurred speech and swelling of certain body areas. Be sure to let your doctor know about any allergies you have experienced.

The US Food and Drug Administration have noted warnings associated with existing health conditions and potential increase of complications when using this medicine. Before you stop treatment, see your doctor – stopping this medicine may cause a low number of platelets increasing your risk of bleeding.

Portal vein thrombosis was reported in patients with chronic liver disease and there are noted increases of risks associated with progression of acute myelogenous leukemia and myelodysplastic syndrome. Medical concerns exist with long-term use, causing harmful effects to bone marrow resulting in blood cell disorders.

Geriatrics

Studies show no difference between elderly patients over the age of 65 compared to elderly patients over 75 years of age. Although some sensitivity varies between these individuals, age is still a factor when considering this treatment. Dose adjustments for this age group have greater interactions due to health conditions and drugs used to manage ailments.

Pregnancy

If you are pregnant or become pregnant during treatment, talk with your doctor. There have been mild cases of a low platelet count when pregnant without life-threatening side effects. There have also been more severe cases with uncontrollable bleeding, needing emergency help.

  • There is limited data on the effects of the unborn child.
  • Pregnancy category C

If you are treated with this medicine, with your approval, your name is added to a registry that collects information about the effects passed on to the child. There is no data to show harmful effects of breast milk containing romiplostim. If you notice unusual symptoms in yourself or your child, contact your doctor at once.

Storage

Romiplostim subcutaneous injections are administered by medical professionals trained to prepare and store this medicine properly. It is stored away from direct light until it’s prepared for use. The vials are refrigerated, but not frozen. Unused portions and used medical supplies are disposed of correctly.

Summary

All patients should understand the risks and the benefits of this treatment. Your doctor will assist in helping you decide based on medical evaluations and critical lab testing to weigh the consequences of treating your health condition. In some cases, this treatment may extend into long-term administration, and the effects could be harmful to your overall health.

 

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Last Reviewed:
January 31, 2018
Last Updated:
February 10, 2018
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