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Treatment Name: Peginterferon alfa-2a (Pegasys®)

Peginterferon alfa-2a (Pegasys®) is an Immunotherapy Regimen for Polycythemia Vera

How does Peginterferon alfa-2a work?
Peginterferon alfa-2a is a designed to slow the growth of red blood cells caused by polycythemia vera (P. Vera). Peginterferon does this by interfering (blocking) a signal inside of cells which is generated by a genetic mutation known as “JAK2”.

Goals of therapy:
Peginterferon alfa-2a is taken to reduce the risk of:

  • blood clots, including deep vein thrombosis, pulmonary embolism, or clots within the liver
  • heart attack
  • stroke

Peginterferon alfa-2a may also decrease symptoms associated with P. Vera such as:

  • headache
  • stroke-like symptoms
  • itching (sometimes worsened after a hot shower)
  • Enlarged spleen causing abdominal discomfort 

Peginterferon alfa-2a prevents the need for phlebotomy in the majority of patients with P. Vera.

Peginterferon alfa-2a is not commonly given with the goal of cure, but has the potential of inducing long-term remissions. Peginterferon has NOT been shown to increase the risk leukemia.

Schedule

  • Once trained, patients themselves, or their family and friends may administer the injection at home
  • Patients should drink plenty of water, especially during the first several months of therapy
  • To reduce the risk of blood clots further, your doctor may also recommend taking a baby aspirin (81 mg) tab by mouth Once Daily 

Click here for Tips on injecting Peginterferon (Pegasys®)

Peginterferon is usually given demonstrated in in the clinic before the first dose, then Peginterferon alfa-2a is usually taken at home.

Peginterferon is repeated every week or 7 days. Treatment may be repeated as long as the medicine is working and unacceptable side effects are not experienced. Sometimes, if a patient achieves a complete hematologic remission and complete molecular remission (all signs of P. Vera are gone), the doctor may decide to stop Peginterferon therapy for a period of time to see if the patient can remain in remission without medication

Click to see which preparations can be used for 45 or 90 mcg doses

Click to see which preparations can be used for 135 mcg doses

Click to see which preparations can be used for 180 mcg doses

Side Effects

In clinical studies, the most commonly reported side effects with peginterferon alfa-2a (Pegasys®) are shown here:

  • Muscle or joint pain (up to 35%)
  • Feeling ill (up to 29%)
  • Depression or other psychiatric event (up to 23%)
  • Skin problems (up to 23%)
  • Fever (up to 19%)
  • Gastrointestinal events [for example diarrhea or constipation] (up to 11%)
  • Thyroid problems (up to 9%)
  • Lack of interest or desire to have intercourse (up to 3%)
  • Heart problems (up to 3%)

Roughly 8% of patients discontinued Peginterferon alfa-2a within the first year due to unacceptable side effects

Side effect videos Side Effect Videos
PainPainBleedingBleedingAnemiaAnemiaBlood ClotsBlood ClotsConstipationConstipationDiarrheaDiarrheaHair LossHair LossFatigue Fatigue

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, weekly for the first month, monthly for 3 months until the 12th month, then every 6 months thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), Uric acid, thyroid function tests (TSH, or free T4 which may be measured every 12 weeks), serum erythropoietin (epo) level, the JAK2V617F mutation, often called “JAK2”, a pregnancy test for women of child-bearing potential, plus any others your doctor may order. Not all labs are checked at every visit.

How often is imaging needed?
Imaging may be checked before treatment, then periodically thereafter, depending upon if the spleen was enlarged before beginning treatment or if side effects develop. Imaging may include: Ultrasound (US) to measure spleen size, or Chest X-ray (if you develop shortness of breath, fever, or cough)

All patients should receive an eye exam before receiving their first dose of peginterferon and anytime they develop eye problems while receiving treatment with peginterferon

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to increase the dose of peginterferon after the first 2 injections (after 2 weeks), then increase the dose by 45 mcg per week every other week until the maximum dose of 180 mcg is achieved. Treatment with peginterferon may also be delayed for side effects, or the dose may be reduced based upon goals of therapy, or changed to a different therapy if side effects are unacceptable

ChemoExperts Tips

  • Acetaminophen (Tylenol) 500 or 650 mg by mouth is often recommended before each Pegasys dose to reduce the chance of fever
  • Pegasys® is NOT FDA-approved for P. Vera and it may require additional steps to gain insurance approval. Often, a letter of medical necessity submitted with a prior authorization form increases the chance of having the medication covered by insurance
  • Symptoms of thyroid problems may include: either feeling cold or hot all of the time, an increase or decrease in weight, skin changes, or trouble concentrating. Hair thinning, without complete hair loss, may be a sign of a thyroid problem as well
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • P. Vera sometimes causes itching after a hot bath or shower. This is known as aquagenic pruritus. A medicine known as “paroxetine,” or “Paxil®,” is sometimes prescribed to decrease itching
  • A puncture-resistant container, such as an empty laundry detergent bottle, can safely store used needles and syringes. This container can then be taken to certain police or fire stations for disposal.
  • Clinical trials may exist for Polycythemia Vera. 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 Peginterferon alfa-2a (Pegasys®), 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 Peginterferon alfa-2a (Pegasys®). Depending upon your income, they may be able to help cover the cost of:

  • Peginterferon alfa-2a

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 Peginterferon alfa-2a (Pegasys®) 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 Peginterferon alfa-2a (Pegasys®)

Individual Drug Label Information

Peginterferon alfa-2a (Pegasys®)

  • Peginterferon alfa-2a is a subcutaneous injection SQ, sometimes referred to as “Sub-Q” 
  • Peginterferon should not be given to patients with autoimmune hepatitis, or patients with moderate to severe liver problems, or with a sensitivity to benzyl alcohol 
  • Life-threatening neurologic problems such as suicidal ideation, depression, relapse of drug addiction, or drug overdose could occur, but are seen in less than 1% of patients. Peginterferon should be used with extreme caution in every patient with a history of depression 
  • Use with caution in patients with anemia (hemoglobin less than 10 g/dL), thrombocytopenia (platelet count less than 90,000 cells/mcL), or neutropenia (Neutrophils less than 1,500 cells/mcL) 
  • Use with caution in patients with a history of autoimmune disorders 
  • Peginterferon should be used with caution in patients with poor kidney function as they may experience more side effects from the medicine. A reduced dosage may be required if alternative medicines are not available 
  • Consider dosing before bedtime to sleep through some of the side effects, should they occur 
  • If you miss a dose, and it is within 2 days, you may take the dose and resume the next dose on the same day that you normally do. If more than 2 days have passed since a missed dose, call your doctor and pharmacist. 
  • Peginterferon should be stored in the refrigerator (36°F – 46°F). Do NOT leave Pegasys out of the fridge for more than 24 hours. Do NOT freeze. Do NOT shake. Protect from light 
  • Dosage adjustments may be required for decreased kidney or liver function 
  • Peginterferon should be used during pregnancy only when the benefit justifies the potential harm to the fetus. A specialist experienced in dosing peginterferon in pregnancy is highly recommended 
  • It is not known whether peginterferon is excreted into breast milk 
  • May interact with methadone. Patients adding peginterferon to methadone therapy should have a dose reduction of methadone and be monitored for methadone toxicity 
General Peginterferon alfa-2a (Pegasys) Side Effects 
  • Fatigue 
  • Fever 
  • Muscle Pain 
  • Headache 
  • Lung problems 
  • Infection 
  • Decreased vision or changes in eye sight
  • High blood pressure 
  • High blood sugar; symptoms include increased thirst, tiredness, increased urination, weight loss 
  • Inflammation in intestine (Colitis) causing abdominal pain or bloody stools 
  • Low or high thyroid hormone levels 
  • Inflammation of pancreas (Pancreatitis) 
  • Heart rhythm problems, chest pain, or heart attack 
  • Nerve pain in hands or feet such as numbness, tingling, or burning 
  • Stroke 
  • Click on the peginterferon alfa-2a (Pegasys) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Hair LossHair LossFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaBlood ClotsBlood Clots

See DailyMed package insert.

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References

Kiladjian JJ, Cassinat B, Chevret S, et al. Pegylated interferon-alfa-2a induces complete hematologic and molecular responses with low toxicity in polycythemia vera. Blood. 2008;112:3065-3072.

Created: May 22, 2016 Updated: August 30, 2016

What is Polycythemia Vera?

Polycythemia refers to an increased production of red blood cells. There can be many causes of this, including smoking, sleep apnea, or living at high altitudes.

Polycythemia Vera, or "P. Vera", also causes increased red blood cell production, and is almost always the result of a gene mutation known as "JAK2V617F."

P. Vera may increase the risk of a blood clot, such as a heart attack or stroke. Very rarely, it may transform into another disease such as myelofibrosis or acute myeloid leukemia, however this often takes several decades.

Peginterferon alfa-2a (Pegasys®) and ruxolitinib (Jakafi®) are common treatments for polycythemia vera. Please click on the treatment options below to learn more.

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 does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Subcutaneous injection technique for the VIAL

a. Take the vial out of the fridge.
b. Never reuse the same vial as they are for single-use only.
c. Do NOT inject through clothing.
d. Check the expiration date to make sure it is not expired.
e. Wash your hands with soap and water for at least 30 seconds.
f. Pick an injection site on around the abdomen (not within 2 inches of the belly-button) or on top of the thigh.
g. Clean the site with an alcohol swab and let dry for 10 seconds. The drying action kills bacteria.
h. Flip off the plastic cap rom the vial and rub the rubber stopper with an alcohol swab. Let dry.
i. Using a 1 or 3 milliliter syringe, attach a needle with a twisting motion
j. Push the needle straight into the vial and withdraw the correct volume of medicine that is equal to your prescribed dose. If you are not sure of the dose or volume, call your doctor.
k. You may change the needle used for removing the medication from the vial to a smaller needle for injecting.
l. With the needle bevel facing up, “Pinch an inch” of skin, then holding the syringe like a pencil, pierce the skin at 45 to 95 degree angle using a “dart-like” motion.
m. Depress the plunger to administer your dose.
n. The injection is now complete and can be lifted away. Push the needle shield over the needle using the table to protect the needle from needle stick injuries. Dispose of the used syringe properly in a sharps container.

Subcutaneous injection technique for the SYRINGE

a. Take the syringe out of the fridge.
b. Never reuse the same pre-filled syringe as they are for single-use only.
c. Do NOT inject through clothing.
d. Check the expiration date to make sure it is not expired.
e. Wash your hands with soap and water for at least 30 seconds.
f. If there is foam in the syringe, put it back in the fridge for use at a later time.
g. Remove the needle from its package, but keep the needle covered with its cap until just before the injection.
h. Remove and throw away the rubber cap from the glass syringe.
i. Screw the needle onto the syringe with a twisting motion and lay it down on a clean, flat surface.
j. Pick an injection site on around the abdomen (not within 2 inches of the belly-button) or on top of the thigh.
k. Clean the site with an alcohol swab and let dry for 10 seconds. The drying action kills bacteria.
l. Remove the cap and point the needle to the ceiling.
m. Tap the syringe, then push the plunger slowly so that air bubbles are removed.
n. The syringe has dosage markings of 90 mcg, 135 mcg, and 180 mcg. Push the plunger so that the edge of the black plunger meets the mark next to the dose your doctor prescribed. In doing so, excess liquid medicine will come out of the syringe.
o. With the needle bevel facing up, “Pinch an inch” of skin, then holding the syringe like a pencil, pierce the skin at 45 to 95 degree angle using a “dart-like” motion.
p. Depress the plunger to administer your dose. q. The injection is now complete and can be lifted away. Push the needle shield over the needle using the table to protect the needle from needle stick injuries. Dispose of the used syringe properly in a sharps container.

Subcutaneous injection technique for the AUTOINJECTOR

a. Take the syringe out of the fridge.
b. Never reuse the same autoinjector as they are for single-use only
c. Do NOT inject through clothing
d. Check the expiration date to make sure it is not expired
e. Wash your hands with soap and water for at least 30 seconds
f. Pick an injection site on around the abdomen (not within 2 inches of the belly-button) or on top of the thigh
g. Clean the site with an alcohol swab and let dry for 10 seconds. The drying action kills bacteria
h. Pull off the blue cap of the injector with one hand and set it down. It will have a loose fitting metal tube
i. “Pinch an inch” of skin, then rest the red needle shield of the injector on the pinched area of skin
j. With the autoinjector at a 90 degree angle, press down firmly until the red needle shield is completely pushed in, which will “unlock” the needle
k. Then press the Blue activation button on the end to release the injection and let go right away
l. Hold the injector against the skin for a full 10 seconds to make sure all medicine is delivered
m. The injection is now complete and can be lifted away. The needle shield will move and protect the needle from needle stick injuries. Dispose of the used autoinjector properly in a sharps container.

Tips on injecting Peginterferon (Pegasys®)

a. When using a vial, take it out of the fridge and allow it to warm up by gently rolling in the palms of your hands for roughly 1 minute.
b. When using a pre-filled syringe, take it out of the fridge and lay it flat on a clean surface. Allow it to come to room temperature to warm up (about 20 minutes). If droplets of water appear, wait until they go away before using.
c. When using an auto-injector, take it out of the fridge and lay it flat on a clean surface. Do NOT take the cap off. Allow it to come to room temperature to warm up (about 20 minutes).
d. Do not shake peginterferon as foaming may occur.
e. Rotate injection sites on both sides of the abdomen, staying a few inches away from the belly-button. Or, when injecting into the thigh, choose a different place each time and switch between the right and left leg each week.

Which preparations can be used for 45 or 90 mcg doses?

  • 180 mcg/1 mL in a Vial
  • 180 mcg/0.5 mL in a Prefilled Syringe

Which preparations can be used for 135 mcg doses?

  • 135 mcg/0.5 mL in an Autoinjector
  • 180 mcg/1 mL in a Vial
  • 180 mcg/0.5 mL in a Prefilled Syringe

Which preparations can be used for 180 mcg doses?

  • 180 mcg/0.5 mL in an Autoinjector
  • 180 mcg/1 mL in a Vial
  • 180 mcg/0.5 mL in a Prefilled Syringe

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