The FDA has approved the disease-modifying medication Plegridy (Peginterferon beta-1a) for the treatment of a relapsing and remitting form of multiple sclerosis.

Plegridy (Pegylated interferon beta-1a) Uses:

• Relapsing Multiple sclerosis:

  • Treatment for those suffering from relapsing forms of multiple sclerosis, such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease Medication

Plegridy (Peginterferon beta-1a) Dose in Adults

Plegridy (Peginterferon beta-1a) Dose in the treatment of Relapsing Multiple sclerosis:

• SubQ:

  • Initial:

    • 63 mcg on 1st day; then 94 mcg on day 15.

  • Maintenance:

    • 125 mcg every 2 weeks beginning on day 29.

• Note:

  • During treatment, analgesics and/or antipyretics may help reduce flu-like symptoms.
     

Plegridy (Peginterferon beta-1a) Dose in Children

Not recommended for use in children.

Plegridy Pregnancy Risk Factor C

• Limited information is available on the pregnancy use of peginterferon alpha-1a.
• Except for people who are at a high risk of acquiring MS, disease-modifying medications for multiple sclerosis (MS) should be discontinued before to a planned pregnancy and should not be resumed during pregnancy.
• For females at high risk for disease reactivation or who are pregnant, consider other drugs than peginterferon Beta-1a.
• For females who have high levels of disease activity, it is a good idea to delay pregnancy. Other agents are better for these patients.

Use of plegridy during breastfeeding

• It is unknown if breast milk contains peginterferon beta-1a.
• Peginterferon beta1a should not be given to nursing mothers, according to the drug manufacturer.

Plegridy (Peginterferon beta-1a) Dose in Kidney Disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling; use with caution in severe renal impairment (CrCl <30 mL/minute).

• Hemodialysis:

  • Partially removed (~24%) by hemodialysis

Plegridy Dose in Liver Disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling; however, not metabolized extensively in the liver.

Common Side Effects of Plegridy (Peginterferon beta-1a):

• Central Nervous System:

  • Headache
  • Chills

• Dermatologic:

  • Injection Site Pruritus

• Local:

  • Injection Site Reaction
  • Erythema At Injection Site
  • Pain At Injection Site

• Neuromuscular & Skeletal:

  • Myalgia
  • Asthenia
  • Arthralgia

• Respiratory:

  • Flu-Like Symptoms

• Miscellaneous:

  • Fever

Less Common Side Effects Of Plegridy (Peginterferon beta-1a):

• Central Nervous System:

  • Increased Body Temperature
  • Pain
  • Hyperthermia

• Dermatologic:

  • Pruritus
  • Rash At Injection Site

• Endocrine & Metabolic:

  • Increased Serum ALT
  • Increased Gamma-Glutamyl Transferase

• Gastrointestinal:

  • Nausea
  • Vomiting

• Hematologic And Oncologic:

  • Decreased White Blood Cell Count

• Hepatic:

  • Increased Serum AST

• Immunologic:

  • Antibody Development

• Local:

  • Hematoma At Injection Site
  • Swelling At Injection Site
  • Warm Sensation At Injection Site

Contraindications to Plegridy (Peginterferon beta-1a):

• Hypersensitivity to interferon beta, natural or recombinant, or any component in the formulation
• There is not much evidence of cross-reactivity between allergenic interferons. Cross-sensitivity is possible due to similarities in chemical structure or pharmacologic effects.

Canadian labeling

• Additional contraindications not listed in the US labeling:
  • Pregnancy
  • Suicidal thoughts and/or severe depression.

Warnings and precautions

• Autoimmune disorders

  • Reports of idiopathic thrombocytopenia and hyper- and hypothyroidism as well as autoimmune hepatitis were made.
  • Patients who develop an autoimmune disorder should be considered for discontinuation of treatment.

• Suppression of bone marrow

  • Could cause decreased peripheral blood cells in all cell types, except for rare cases of severe thrombocytopenia or pancytopenia.
  • Monitor CBC with differentials and platelets. Check for bleeding and other symptoms.
  • Patients suffering from myelosuppression might need to be monitored more closely.

• Hepatic effects

  • There have been reports of severe hepatic injury (autoimmune hepatitis and severe hepatic dysfunction) and asymptomatic elevations in hepatic transaminases.
  • Be aware of signs and symptoms that could indicate a hepatic injury.

• Hypersensitivity

  • Anaphylaxis or other severe allergic reactions, such as angioedema and urticaria, may occur (rare).
  • If you experience severe allergic reactions, stop taking medication and seek supportive treatment.

• Reactions at the injection site:

  • Subcutaneous use can cause injection site reactions, such as pain, pruritus and necrosis.
  • Avoid administering to necrosis at one site. If multiple lesions are present, stop the administration until healing takes place.

• Neuropsychiatric disorders

  • Suicidal ideation, depression and suicide are all common.
  • If you experience depression or severe psychiatric symptoms, it is worth considering quitting treatment.

• Thrombotic microangiopathy

  • TMA, which encompasses hemolytic uremic disease or thrombotic thrombocytopenic purpura, has been associated to interferon beta products (HUS). Several instances of this fatality were documented.
  • Patients have described cases that occurred a few weeks to years after beginning treatment.
  • Keep an eye out for symptoms of newly developing hypertension, such as thrombocytopenia or renal dysfunction.
  • Stop using it in patients with TMA.

• Cardiovascular disease

  • Interferon beta may cause congestive heart disease (CHF), cardiomyopathy and cardiomyopathy with CHF in patients who receive the drug.
  • Monitor patients with severe cardiac disease to monitor for any changes in their condition.

• Renal impairment

  • Take extra care if you have severe renal impairment. You may experience increased drug exposure. Monitor for adverse reactions.

• Seizures

  • This medication can cause seizures.

Pegylated interferon (peginterferon) beta-1a: Drug Interaction

Monitoring Parameters:

• CBC with differential and platelets,
• transaminase levels;
• signs and symptoms of hepatic injury,
• hypersensitivity,
• infections,
• bleeding,
• new onset autoimmune disorders,
• injection site reactions;
• signs/symptoms of thrombotic microangiopathy (eg, new-onset hypertension, thrombocytopenia, renal impairment).

How to administer Plegridy (Peginterferon beta-1a)?

• Subcutaneous:

  • You should administer the first injection under the supervision and guidance of a healthcare professional.
  • Subcutaneously administer in the abdomen, back, upper arm or thigh. Rotate injection sites. Do not inject into areas that are red, irritated or scarred.

Mechanism of action of Plegridy (Peginterferon beta-1a):

• Interferon beta is a protein that affects the expression and reaction to surface antibodies and can boost immune cell activity. It differs from naturally occurring human proteins by one amino acid substitution and the absence of a carbohydrate side chain.
• Cell surface receptor interactions are responsible for interferon beta's biologic properties.
• Multiple sclerosis treatment is not understood.

Metabolism:

• Not extensively metabolized in the liver

Half-life elimination:

• ~78 hours (multiple sclerosis patients)

Time to peak:

• 1 to 1.5 days

Excretion:

• Urine (major)

International Brands of Peginterferon beta-1a:

• Plegridy
• Plegridy Starter Pack

Pegylated interferon beta-1a Brands Names in Pakistan:

No Brands Available in Pakistan.