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All about: Peginterferon Alfa-2b

Big Image Pronouncation: (peg-IN-ter-FEER-ahn AL-fuh-2b)
Class: Immunomodulator

Trade Names:
PEG-Intron
- Powder for injection, lyophilized 100 mcg/mL (reconstituted)
- Powder for injection, lyophilized 160 mcg/mL (reconstituted)
- Powder for injection, lyophilized 240 mcg/mL (reconstituted)
- Powder for injection, lyophilized 300 mcg/mL (reconstituted)

Mechanism of Action

Pharmacology

Binds to specific membrane receptors on cell surface and initiates a complex sequence of intracellular events (eg, suppression of cell proliferation, enhancement of phagocytic activity of macrophages).

Pharmacokinetics

Absorption

T max is 15 to 44 hr (postdose). Bioavailability increases with multiple dosing. Both AUC and C max increased 70% when administered with a high-fat meal.

Elimination

Renal excretion is 30%. The t 1/ 2 absorption is 4.6 hr (subcutaneous) and elimination is approximately 40 hr. Apparent Cl is 22 mL/hr•kg.

Duration

Duration is 48 to 72 hr.

Special Populations

Renal Function Impairment

Cl decreases 50% when Ccr is less than 50 mL/min.

Indications and Usage

For use alone or in combination with ribavirin for the treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease.

Unlabeled Uses

Renal carcinoma.

Contraindications

Autoimmune hepatitis; decompensated liver disease; hypersensitivity to the drug.

Dosage and Administration

Once Weekly (on Same Day of Week) for 1 yr; Initial Dose Based on Weight
Adults

Subcutaneous For patients weighing 45 kg or less, administer 40 mcg; 46 to 56 kg, administer 50 mcg; 57 to 72 kg, administer 64 mcg; 73 to 88 kg, administer 80 mcg; 89 to 106 kg, administer 96 mcg; 107 to 136 kg, administer 120 mcg; 137 to 160 kg, administer 150 mcg.

Peginterferon Alfa-2b Dose in Combination Therapy with Ribavirin
Adults

Subcutaneous For patients weighing less than 40 kg, administer 50 mcg; 40 to 50 kg, administer 64 mcg; 51 to 60 kg, administer 80 mcg; 61 to 75 kg, administer 96 mcg; 76 to 85 kg, administer 120 mcg; greater than 85 kg, administer 150 mcg.

Dose Reduction

If a serious adverse reaction develops during treatment, discontinue or modify dosage to 50% of the starting dose until reaction abates or decreases in severity.

General Advice

  • For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
  • Administer dose at bedtime to minimize flu-like symptoms.
  • Administer antipyretics as ordered as pretreatment to minimize flu-like symptoms.
  • Reconstitute powder for injection in vials or Redipen following manufacturer's instructions.
  • Do not reconstitute with any solution other than that provided with the powder for injection nor add any other medications to reconstituted solution.
  • Do not shake solution during reconstitution process. Gently invert Redipen or gently swirl contents in vial to obtain a clear, colorless solution.
  • Do not administer if solution is discolored or cloudy, or if particulate matter is noted.
  • Use only 1 dose/vial or pen. Do not re-enter vial. Discard any unused portions. Do not save unused solution for later administration.

Storage/Stability

Store unopened vials at controlled room temperature (59° to 86°F). Store Redipen in refrigerator (36° to 46°F). Administer reconstituted solution immediately or store for up to 24 hr in refrigerator. Do not freeze.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Cardiac ischemia (postmarketing).

CNS

Fatigue/asthenia (66%); headache (62%); anxiety, emotional lability, irritability (47%); insomnia (40%); depression (31%); dizziness (21%); impaired concentration (17%); agitation, nervousness (8%); peripheral neuropathy, seizures, vertigo (postmarketing).

Dermatologic

Alopecia (36%); pruritus (29%); rash, dry skin (24%); increased sweating (11%); flushing (6%); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

Pharyngitis (12%); rhinitis (8%); blurred vision (5%); conjunctivitis (4%); hearing impairment or loss (postmarketing).

Endocrine

Hypothyroidism (5%).

GI

Nausea (43%); anorexia (32%); diarrhea (22%); abdominal pain (15%); vomiting (14%); dry mouth (12%); dyspepsia, taste perversion (9%); constipation (5%); stomatitis (postmarketing).

Genitourinary

Menstrual disorder (7%); renal failure, renal insufficiency (postmarketing).

Hematologic-Lymphatic

Neutropenia (26%); anemia (12%); leukopenia (6%); thrombocytopenia (5%).

Hepatic

Hepatomegaly (6%).

Lab Tests

Decreased neutrophils (70%); decreased platelets (20%); hypothyroidism (5%); hyperthyroidism (3%).

Local

Injection site inflammation/reaction (75%).

Metabolic-Nutritional

Decreased weight (29%).

Musculoskeletal

Myalgia (56%); rigors (48%); arthralgia (34%); MUSC pain (28%); rhabdomyolysis (postmarketing).

Respiratory

Dyspnea (26%); coughing (23%); sinusitis (6%).

Miscellaneous

Right upper quadrant pain (48%); fever (46%); viral infection (12%); chest pain (8%); malaise (7%); fungal infection (6%).

Precautions

Warnings

Neuropsychiatric, autoimmune, ischemic, and infectious disorders

Interferons may cause or aggravate fatal or life-threatening disorders of this nature. Persistent, severe, or worsening signs or symptoms may necessitate discontinuation of therapy. Closely monitor patients with periodic clinical and laboratory evaluations.


Monitor

Hepatitis C virus levels

Determine hepatitis C virus levels before starting therapy and after 6 mo of therapy. Be prepared to discontinue therapy if viral levels remain high after 6 mo of therapy.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution.

Renal Function

Use with caution and monitor for signs and symptoms of interferon toxicity.

Autoimmune disorders

Because interferon alfa may cause or exacerbate autoimmune disorders (eg, thyroiditis, SLE), use with caution in patients with history of autoimmune disorders. Discontinue use in patients with persistently severe or worsening signs or symptoms.

Bone marrow toxicity

Bone marrow function may be suppressed.

CV events

Use with caution in patients with CV disease, including hypotension, arrhythmia, tachycardia, cardiomyopathy, and MI.

Colitis

Fatal and nonfatal ulcerative and hemorrhagic colitis have been observed. Discontinue use immediately in patients who develop symptoms.

Endocrine disorders

Hypo- and hyperthyroidism may occur or be aggravated. Diabetes mellitus has been observed in treated patients.

Hypersensitivity

Serious, acute hypersensitivity reactions (eg, angioedema, anaphylaxis) may occur with alfa interferon therapy.

Infectious disorders

Because life-threatening infectious disorders may occur, use with caution and monitor with periodic clinical and laboratory evaluations. Discontinue use in patients with persistently severe or worsening signs or symptoms.

Neuropsychiatric events

Because life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction, and aggressive behavior have occurred, use with caution, especially in patients with history of psychiatric disorder. Discontinue use in patients with persistently severe or worsening signs or symptoms.

Ophthalmic disorders

Decrease or loss of vision, retinal hemorrhages, cotton wool spots, and retinal artery or vein obstruction have been observed. Ensure that all patients have an ophthalmic examination prior to beginning therapy and that patients with preexisting ophthalmic disorders (eg, diabetic, hypertensive retinopathy) receive periodic ophthalmic examinations during therapy.

Pancreatitis

Fatal and nonfatal pancreatitis has been observed. Discontinue use in patients who develop symptoms.

Pulmonary disorders

Dyspnea, pulmonary infiltrates, pneumonia, pneumonitis and sarcoidosis, some resulting in respiratory failure and/or patient deaths have been associated with use.

Triglycerides

Elevated triglyceride levels may occur.

Patient Information

  • Explain name, dose, action, and potential side effects of drug.
  • If patient will be self-administering at home, review Medication Guide with the patient. Ensure that the patient understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
  • Remind patient that prescribed dose is administered once weekly and should be administered on the same day of the week.
  • Caution patient not to change the dose or stop taking unless advised by health care provider.
  • Advise patient that dose may be reduced or the medication stopped if it causes depression or significant changes in blood cell counts.
  • Teach patient infection control and bleeding precautions.
  • Advise patient that it is not known if this drug will prevent transmission of hepatitis C to others, nor is it known if it can prevent cirrhosis, liver failure, or liver cancer that may develop as a result of hepatitis C infection.
  • Instruct patient to immediately report any of the following to health care provider: signs or feelings of depression and/or suicidal ideation; fever; sore throat; unusual bleeding or bruising; stomach pain; bloody diarrhea; rapid or irregular pulse; difficulty breathing or unexplained shortness of breath.
  • Advise women of childbearing potential to use effective contraception during treatment.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Caution patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
  • Advise patient that follow-up visits and frequent lab tests will be required to monitor therapy and keep appointments.

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