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Treatment Name: Romiplostim (Nplate®)

Romiplostim (Nplate®) is a Treatment Regimen for Immune Thrombocytopenic Purpura (ITP)

How does romiplostim (Nplate®) work?
Romiplostim is a man-made protein that is designed to bind to the cells that make platelets in your bone marrow and tell these cells to make more platelets.

Goals of therapy:
Romiplostim is given to patients with low platelet counts in order to increase the platelet count to a range that will prevent potentially life-threatening bleeding. Although romiplostim can increase the platelet count to a safe range, it is generally not considered a cure for ITP.

By increasing the platelet count to a goal of usually 50 k/μL or higher, the risk of bruising and bleeding (both spontaneous and injury-induced) is decreased.

Romiplostim may be used for patients with low platelet counts if the following treatments do not work: dexamethasone, prednisone, immune globulin infusions, or for patients with low platelets after spleen removal.

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Schedule

Usual romiplostim (Nplate®) starting dose:

  • Romiplostim 1 mcg/kg (actual body weight) subcutaneous injection, Once Weekly
    • Example: Patient weight of 150 lbs. = 68 kg, therefore the dose would be 68 mcg subcutaneously once weekly
  • The dose should be increased slowly (example: increase by 1 mcg/kg per week) to prevent the platelet count from increasing too much, but to achieve a platelet count above 50 k/μL
  • Once prepared in a syringe, the dose should be protected from light and administered within 24 hours. The volume of romiplostim will be very small, and often less than 1 mL
  • Maximum dose: Romiplostim 10 mcg/kg subcutaneously once weekly

Estimated total time to receive this treatment:

  • Up to 90 minutes for each weekly dose
  • Clinic staff may need to wait for the results of blood tests to determine the weekly dose
  • Once the dose is determined, the pharmacy needs to prepare the dose in an I.V. Room, which requires additional time
  • Pre-medication is not required to receive romiplostim

Romiplostim is usually given in an outpatient infusion center or in a clinic, allowing the person to go home afterwards. Most insurance policies do not allow patients to take romiplostim home for self-injection because of the risk of inadvertent overdose; there is a special dilution process required to prepare a dose. On occasion, romiplostim may be given in the hospital if someone is too sick to receive it in the outpatient setting.

Romiplostim is repeated every 7 days depending upon response, and tolerability. Missing a scheduled dose of romiplostim may increase the risk of bleeding.

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Side Effects

In clinical studies, the most commonly reported romiplostim (Nplate) side effects are shown here:

Important Notes regarding romiplostim:

1) Too much romiplostim may increase the risk for blood clots, leading to swelling in legs, difficulty breathing, a heart attack, or stroke

2) Bruising is likely to be more common when your platelets are low and is seen most commonly in the first two weeks from beginning romiplostim therapy. Spontaneous bruising or bleeding events are rare once your platelets rise above 50 k/μL

3) Sometimes corticosteroids such as dexamethasone or prednisone are given to increase the platelet count while awaiting a response from romiplostim. As such, some side effects listed above may be due to these steroids, rather than romiplostim

Side effect videos Side Effect Videos
BleedingBleedingFatigue Fatigue Nausea and VomitingNausea and VomitingPainPainAnemiaAnemiaBlood ClotsBlood Clots

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, weekly for at least four weeks using the same dose, then either weekly or monthly thereafter depending upon the platelet count each time it is checked. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), coagulation tests such as the prothrombin time (PT), or activated partial thromboplastin time (aPTT), plus any others your doctor may order.

How often is imaging needed?
Imaging is not usually needed during therapy with romiplostim. Imaging may be checked if there are signs or symptoms of a respiratory tract infection, or if there is suspected bleeding in the head. Imaging may include: chest X-ray (CXR) or computerized tomography (CT) scan.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue romiplostim (Nplate) as planned, reduce the dose of future treatments, increase the dose of future treatments, delay the next dose until the side effect goes away or the platelet count returns to the normal range, or switch to an alternative therapy. It is very important to have routine blood tests when recommended by your doctor. This will help with romiplostim dose adjustments. It is common to have frequent blood tests when first starting therapy. Over time, the number of blood tests usually decreases when the platelet count is in a safe range and the dose is no longer changing from week to week.

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ChemoExperts Tips

  • If you discontinue romiplostim therapy, your platelet count may drop to a level that is lower than when it was started. Lab tests to check platelet counts should continue weekly for at least 2 weeks after your last planned dose
  • Fibrous tissue formation in the bone marrow (reticulin fiber and collagen fibrosis) is rare but has been associated with romiplostim injections; the long-term risks of this are unknown
  • Headache, if it occurs, is usually controlled with acetaminophen (Tylenol®)
  • Remember to keep your medication list updated each time you receive a new medication. It is important that the doctors and pharmacists have an accurate list of the medications you are taking to minimize your risk of bleeding or clotting. A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for ITP. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Romiplostim (Nplate®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Romiplostim (Nplate®). Depending upon your income, they may be able to help cover the cost of:

  • Romiplos­tim

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Romiplostim (Nplate®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Romiplostim (Nplate®)

Individual Drug Label Information

Romiplos­tim (Nplate®)

  • Romiplostim is a subcutaneous injection into the skin
  • It is supplied in 250 mcg and 500 mcg vials. Each patient’s dose will be determined based upon their actual body weight and platelet count at the time of dosing
  • Injection site irritation may occur
  • Romiplostim should NOT be given intravenously
  • Romiplostim should NOT be used to treat a low platelet count resulting from myelodysplastic syndrome (MDS)
  • It is important to take this on the same day of the week every week. Delaying doses can lead to a dangerously low platelet count
  • Romiplostim may harm an unborn baby based upon animal data. The benefits and risks of taking it during pregnancy or nursing should be discussed with your doctor
  • A surveillance program for women who become pregnant while taking Nplate has been established in order to collect additional information about the effects in pregnancy. Patients or physicians may enroll by calling 1-800-77-AMGEN (1-800-772-6436)
General side effects from romiplostim (Nplate®)
  • Headache
  • Joint pain [arthralgia] 
  • Dizziness
  • Trouble sleeping
  • Muscle pain [myalgia]
  • Pain in arms or legs
  • Abdominal pain
  • Shoulder pain
  • Heartburn Pins or needles sensation in hands or feet
  • Blood clots
  • Click on the romiplostim (Nplate®) package insert below for reported side effects, possible drug interactions, and other romiplostim prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaBlood ClotsBlood Clots

See DailyMed package insert.

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References

1) Bussel JB, Kuter DJ, George JN, et al. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006;355:1672–1681.

2) Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371:395–403.

Created: December 12, 2016 Updated: January 8, 2017

What is Immune Thrombocytopenic Purpura (ITP)?

A disorder where platelets decrease in number due to decreased production in the bone marrow and increased destruction in the blood. This can lead to an increased risk of spontaneous bruising or bleeding (without injury), especially when the platelet count drops below 30,000 cells per microliter of blood.

I  = Immune, ITP is caused by a disturbance in the immune system
T  = Thrombocytopenic, a medical term meaning low platelet count
P  = Purpura, a type of bleeding in the skin

ITP is NOT a cancer, but it is commonly managed by hematologists (blood doctors) who often treat blood cancers as well. ITP is an uncommon condition and may be caused by auto-immune disorders, infections, certain medications, or pregnancy. However, in many cases, a cause cannot be identified which gives rise to its other name-idiopathic (meaning “cause unknown”) thrombocytopenic purpura. Although ITP may spontaneously resolve, for some patients lifelong therapy may be needed.

The effectiveness of medications may depend upon the causes of ITP and the ability to remove these causes, or whether a splenectomy (removal of the spleen) has been performed, or is able to be performed.

Deciding on a treatment for ITP is in a way like buying, owning, and driving a car. Think about the following similarities to help you understand which treatment is right for you:

BUYING: "0 - 50 time" (0 to 50 k/µL platelets, instead of 0 - 60 m.p.h) is an important performance feature
Once the platelet count exceeds 50 k/µL, bleeding episodes are rare. Therefore, the time it takes to go from very few platelets to a platelet count over 50 k/µL matters. In general, steroids such as prednisone and dexamethasone have the fastest "0 - 50" time.

  • Although exceptions, the thrombopoeitin receptor agonists romiplostim and eltrombopag usually have a 0 - 50 k/µL platelet time of 1 - 2 weeks
  • Although exceptions, one-half of rituximab recipients have a 0 - 50 k/µL platelet time below 5.5 weeks, and the other half over 5.5 weeks. The response to rituximab is often unpredictable

OWNING: Warranty offered?
A 5-year bumper-to-bumper warranty helps us worry less about something breaking or going wrong with our vehicle after we buy it. Likewise, not all medications used for ITP have a long-lasting effect in keeping the platelet count above 50 k/µL.

  • When it works, rituximab can work for 1 - 2 years, but lasting responses beyond two years are rarer. The 5 year rituximab response rate is estimated at 20 - 25%. When the rituximab "warranty" runs out and platelets fall, patients with ITP that had a long lasting response to rituximab may respond to another course of therapy. Certain insurances require the platelet count to be less than 30 k/µL before it will be covered.
  • When they work, the thrombopoeitin receptor agonists romiplostim and eltrombopag generally have lasting effect beyond that of rituximab. The "warranty" period where the platelet count remains above 50 k/µL often lasts 2 years or longer

DRIVING: Cruise control optional?
The ability for a treatment to maintain the platelet count within the goal range is similar to setting the cruise control on a car.

  • Steroids are given in a pulse (example: dexamethasone daily for 4 consecutive days) or given daily for several weeks (example: prednisone), then decreased over several weeks and eventually discontinued a few months after it is started. As a result, when steroids are no longer taken there is a chance for ITP to relapse
  • Because eltrombopag and romiplostim are administered continuously, these medications have the highest likelihood of keeping the platelet count in the goal range for the long haul
  • Rituximab is typically given once weekly for 4 doses, and usually takes several weeks to determine if it is working (see above), therefore it is difficult to predict who will have a lasting response to this therapy
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is k/μL?

It is an abbreviation for thousand per microLiter, which is a measurement of quantity per volume unit of blood.