Pegasys Proclick

>10%

Fatigue (24% to 67% )

Headache (27% to 54% )

Fever (24% to 54% )

Myalgia (26% to 51% )

Influenza-like illness (25% to 47% )

Rigor (25% to 47% )

Neutropenia (21% to 40% )

Anxiety (19% to 33% )

Feeling nervous (19% to 33% )

Irritability (19% to 33% )

Diarrhea (11% to 31% )

Injection site inflammation (10% to 31% )

Insomnia (19% to 30% )

Arthralgia (22% to 28% )

Alopecia (18% to 28% )

Abdominal pain (8% to 26% )

Nausea and vomiting (5% to 25% )

Loss of appetite (16% to 24% )

Injection site reaction (22% to 23% )

Dizziness (13% to 23% )

Depression (18% to 20% )

Pruritus (12% to 19% )

Dermatitis (8% to 16% )

Weight decreased (4% to 16% )

Lymphocytopenia (Severe) (5% to 14% )

Anemia (2% to 14%)

Lymphocyte count abnormal (3% to 14% )

Dyspnea (4% to 13% )

1-10%

Reduced concentration (8% to 10% )

Cough (4% to 10% )

Dry skin (4% to 10% )

Rash (5% to 8% )

Thrombocytopenia (5% to 8% )

Bacterial infectious disease (3% to 5% )

Severe bacterial infection (1-3%)

<1%

Angina

Cardiac dysrhythmia

Aggressive behavior

Cerebral hemorrhage

Cerebral ischemia

Coma

Drug Abuse

Peripheral neuropathy

Psychotic disorder

Suicide

Diabetes mellitus

Colitis

Gastrointestinal hemorrhage

Pancreatitis

Peptic ulcer disease

Aplastic anemia

Thrombotic thrombocytopenic purpura

Abnormal liver function

Cholangitis

Liver failure

Steatosis of liver

Myositis

Corneal ulcer

Pulmonary embolism

Frequency Not Defined

Myocardial infarction

Erythroderma (rare)

Stevens-Johnson syndrome (rare)

Hypo/hyperthyroidism

Hypo/hyperglycemia

Anemia (severe)

Cytopenia (severe)

Autoimmune disease (rare)

Hypersensitivity reaction (severe)

Serous retinal detachment

Pulmonary infiltrates

Liver graft rejection and renal graft rejection

Postmarketing Reports

Pure red cell aplasia

Hearing impairment

Hearing loss

Tongue pigmentation

Dehydration

Serious skin reactions

Seizures

Liver graft rejection and renal graft rejection

Mechanism of Action

Recombinant alfa-2a interferon w/ polyethylene glycol (PEG) side chain

Immunomodulatory cytokine that enhances phagocytic activity of macrophages and cytotoxic activity of lymphocytes for target cells

Pharmacokinetics

Half-Life: 80 hr

Peak Plasma Time: 72-96 hr

Total Body Clearance: 94 mL/hr

Metabolism: Conjugation w/ polyethylene glycol slows metabolism

Enzymes Inhibited: CYP1A2

This section provides information on the proper use of a number of products that contain peginterferon alfa-2a. It may not be specific to Pegasys Proclick. Please read with care.

A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin, usually in the stomach or thighs. You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

Each package of peginterferon alfa-2a contains a Medication Guide. Read the instructions carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable.

If you have any questions about any of this, check with your doctor.

This medicine is available in 3 dosage forms: a vial (glass container), a prefilled syringe, or a disposable autoinjector. If you switch from using the vial to using the prefilled syringe or autoinjector, double-check that you are giving yourself the correct amount of medicine.

Use each vial, syringe, or autoinjector only one time. You might not use all of the medicine. Do not save an open vial, syringe, or autoinjector. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Drink extra fluids while you are using this medicine. This will keep you well hydrated, especially during the early part of your treatment.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For hepatitis B and hepatitis C:
    • Adults—Dose is based on body weight and must be determined by your doctor. It is usually 180 micrograms (mcg) injected under the skin once a week for 48 weeks. The medicine should be used on the same day each week and at approximately the same time.
    • Children—Use and dose must be determined by your doctor.
  • For hepatitis C infection, in combination with ribavirin:
    • Adults—Dose is based on body weight and must be determined by your doctor. It is usually 180 micrograms (mcg) injected under the skin once a week (same time and day each week) together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your doctor.
    • Children 5 years of age and older—Dose is based on body weight or body size and must be determined by your doctor. It is usually 180 mcg injected under the skin once a week (same time and day each week) together with oral ribavirin twice daily for 24 to 48 weeks. The length of time will be determined by your doctor.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine and you are 1 or 2 days late, use it as soon as you can. If it has been more than 2 days since you were supposed to use the medicine, call your doctor for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Do not leave this medicine out of the refrigerator for more than 24 hours. Do not freeze or shake. Protect it from light.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• chills
• cough
• discouragement
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• painful or difficult urination
• pale skin
• shortness of breath
• sore throat
• tiredness
• trouble sleeping
• trouble with concentrating
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

• Bone pain
• chest pain or discomfort
• confusion
• constipation
• depressed mood
• dizziness
• dry skin and hair
• fainting
• fast heartbeat
• feeling cold
• hair loss
• headache
• heart murmur
• hives
• hoarseness or husky voice
• lightheadedness
• muscle cramps and stiffness
• pale skin
• rapid, shallow breathing
• slowed heartbeat
• sneezing
• stomach pain
• tightness in the chest
• troubled breathing with exertion
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• diarrhea
• dry mouth
• fear
• feeling unusually cold, shivering
• hair loss or thinning of the hair
• muscle or joint pain
• nervousness
• numbness
• pain
• rash
• redness
• scarring
• soreness
• stinging
• stomach pain
• swelling
• tenderness
• tingling
• ulceration
• vomiting
• warmth

• Acid or sour stomach
• belching
• blurred vision
• heartburn
• indigestion
• memory problems
• stomach discomfort or upset

• Change of hearing
• loss of hearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat hepatitis B and C infections.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Pegasys ProClick affects you.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have an eye exam as you have been told by your doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Avoid drinking alcohol while taking this medicine.
• Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with Pegasys ProClick. Call your doctor right away if you have very bad stomach pain, very bad back pain, or very upset stomach or throwing up.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad and sometimes deadly lung problems have happened with this medicine. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• It is not known if Pegasys ProClick will prevent liver failure or other liver problems like cancer. Talk with the doctor.
• This medicine may be used with ribavirin. If you are also taking ribavirin, talk with the doctor about the risks and side effects that may happen.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Not hungry.
• Dizziness.
• Hair loss.
• Not able to sleep.
• Feeling tired or weak.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to peginterferon alfa-2a: subcutaneous kit, subcutaneous solution

General

During hepatitis C studies, at least 1 serious side effect was reported in 10% of chronic hepatitis C (CHC) patients and 19% of CHC patients coinfected with HIV. The most common serious side effect was bacterial infection (including sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other serious side effects were suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (e.g., hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, cerebral hemorrhage, thrombotic thrombocytopenic purpura, psychotic disorder, and hallucination. The most common side effects were psychiatric reactions (including depression, insomnia, irritability, anxiety), influenza-like symptoms (such as fatigue, pyrexia, myalgia, headache, rigors), anorexia, nausea and vomiting, diarrhea, arthralgias, injection site reactions, alopecia, and pruritus. Psychiatric disorders, influenza-like syndrome (e.g., lethargy, fatigue, headache), dermatologic disorders, gastrointestinal disorders, and laboratory abnormalities (thrombocytopenia, neutropenia, anemia) were the most common reasons for discontinuation of therapy.

In clinical trials, patients with chronic hepatitis B had similar side effects as CHC patients using peginterferon alfa-2a monotherapy, except for exacerbations of hepatitis. The most common or important serious side effects in the hepatitis B studies were infections (sepsis, appendicitis, tuberculosis, influenza), hepatitis B flares, thrombotic thrombocytopenic purpura, pyrexia, headache, fatigue, myalgia, alopecia, and anorexia. Therapy was discontinued most often due to laboratory abnormalities (neutropenia, thrombocytopenia, ALT elevation).[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 89%), headache (up to 56%), concentration impairment
Common (1% to 10%): Vertigo, syncope, migraine, memory impairment, weakness, hypoesthesia, hyperesthesia, paresthesia, tremor, taste disturbance, somnolence, tinnitus
Uncommon (0.1% to 1%): Peripheral neuropathy, hearing loss
Rare (0.01% to 0.1%): Cerebral hemorrhage, coma, convulsions, facial palsy
Frequency not reported: Cerebral ischemia, chorea and akathisia
Postmarketing reports: Seizures, hearing impairment[Ref]

Headache (monotherapy: up to 54%; combination therapy: 43%), dizziness excluding vertigo (monotherapy: 16%; combination therapy: 14%), and memory impairment (monotherapy: 5%; combination therapy: 5%) have been reported in CHC patients.

Tinnitus was reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.

A 40-year-old male coinfected with hepatitis C virus and HIV experienced chorea and akathisia coincident with peginterferon alfa-2a therapy. He was administered subcutaneous peginterferon alfa-2a 180 mcg weekly and oral ribavirin 1 g daily. At week 20 of therapy, the patient presented to the clinic complaining of irritability, difficulty in sleeping, and prominent choreiform involuntary movements with myoclonic activity of the upper and lower extremities. He was diagnosed with chorea and akathisia. He was treated with ropinirole, propranolol, and clonazepam. Peginterferon alfa-2a and ribavirin were discontinued with complete resolution of symptoms after 5 days.[Ref]

Other

Very common (10% or more): Influenza-like signs/symptoms, fatigue/asthenia (up to 65%), pyrexia (up to 54%), fatigue (up to 51%), rigors (up to 35%), asthenia (up to 30%), pain (up to 11%), overall resistance mechanism disorders (up to 12%)
Common (1% to 10%): Fever, chills, chest pain, influenza-like illness, malaise, lethargy, shivering, hot flushes, thirst, infections (fungal, viral, bacterial), peripheral edema, flushing, earache
Rare (0.01% to 0.1%): Mucosal hyperpigmentation, otitis externa, substance overdose
Frequency not reported: Bacterial infections (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia), infections (appendicitis, tuberculosis, influenza)[Ref]

Influenza-like signs and symptoms (fatigue/asthenia [monotherapy: 56%; combination therapy: 65%], pyrexia [monotherapy: up to 54%; combination therapy: 41%], rigors [monotherapy: 35%; combination therapy: 25%], pain [monotherapy: 11%; combination therapy: 10%]) and overall resistance mechanism disorders (monotherapy: 10%; combination therapy: 12%) have been reported in CHC patients.

The most common or important serious side effects reported during hepatitis B studies have included infections (sepsis, appendicitis, tuberculosis, influenza).

Fatigue has been reported in 24% of patients during hepatitis B studies.[Ref]

Musculoskeletal

Myalgia (monotherapy: up to 37%; combination therapy: 40%), arthralgia (monotherapy: 28%; combination therapy: 22%), and back pain (monotherapy: 9%; combination therapy: 5%) have been reported in CHC patients.[Ref]

Very common (10% or more): Myalgia (up to 44%), arthralgia (up to 32%)
Common (1% to 10%): Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskeletal pain, muscle cramps
Rare (0.01% to 0.1%): Myositis
Frequency not reported: Rhabdomyolysis[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 40%), anemia (up to 28%), lymphopenia (up to 14%)
Common (1% to 10%): Thrombocytopenia, lymphadenopathy
Rare (0.01% to 0.1%): Pancytopenia
Very rare (less than 0.01%): Aplastic anemia, idiopathic or thrombotic thrombocytopenic purpura
Frequency not reported: Leukopenia, decreased hemoglobin, decreased absolute CD4+ cell count (without decrease in CD4+ cell percentage)
Postmarketing reports: Pure red cell aplasia[Ref]

Neutropenia (monotherapy: 21%; combination therapy: up to 40%), lymphopenia (monotherapy: 3%; combination therapy: 14%), anemia (monotherapy: 2%; combination therapy: up to 14%), and thrombocytopenia (monotherapy: 5%; combination therapy: up to 8%) have been reported in CHC patients.

Moderate (absolute neutrophil count [ANC] 0.5 to 0.749 x 10[9]/L: 24%) and severe (ANC less than 0.5 x 10[9]/L: 5%) neutropenia was reported in patients using peginterferon alfa-2a plus ribavirin for 48 weeks.

In 1 study, CHC patients with advanced fibrosis or cirrhosis and baseline platelet counts as low as 50,000/mm3 were treated for 48 weeks. Hematologic laboratory abnormalities in the first 20 weeks included ANC less than 750/mm3 (30%), hemoglobin less than 10 g/dL (26.3%), and platelets less than 50,000/mm3 (13%).

Neutropenia (40%), anemia (14%), and thrombocytopenia (8%) have been reported during treatment with peginterferon alfa-2a plus ribavirin in CHC patients coinfected with HIV. Decrease in ANC levels below 500 cells/mm3 (monotherapy: 13%; combination therapy: 11%), decrease in platelets below 50,000/mm3 (monotherapy: 10%; combination therapy: 8%), and hemoglobin less than 10 g/dL (monotherapy: 7%; combination therapy: up to 28%) were reported in coinfected patients.

Laboratory abnormalities (thrombocytopenia, neutropenia, anemia) were among the most common reasons given for discontinuation of therapy.

The most common or important serious side effects reported during hepatitis B studies have included thrombotic thrombocytopenic purpura.[Ref]

Gastrointestinal

Gastrointestinal side effects were among the most common reasons given for discontinuation of therapy.

Nausea/vomiting (monotherapy: 24%; combination therapy: 25%), diarrhea (monotherapy: 16%; combination therapy: 11%), abdominal pain (monotherapy: 15%; combination therapy: 8%), dry mouth (monotherapy: 6%; combination therapy: 4%), and dyspepsia (monotherapy: less than 1%; combination therapy: 6%) have been reported in CHC patients.

Cheilitis was reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.[Ref]

Very common (10% or more): Nausea (up to 40%), diarrhea (up to 26%), nausea/vomiting (up to 25%), abdominal pain (up to 15%), vomiting (up to 13%), upper abdominal pain (up to 12%)
Common (1% to 10%): Dry mouth, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, gastritis, gingivitis, cheilitis, constipation, oral candidiasis
Uncommon (0.1% to 1%): Gastrointestinal bleeding
Rare (0.01% to 0.1%): Tongue hyperpigmentation, peptic ulcer, pancreatitis
Frequency not reported: Colitis, ischemic colitis, reversible pancreatic reaction (i.e., increased amylase/lipase with or without abdominal pain)
Postmarketing reports: Tongue pigmentation[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 36%), irritability/anxiety/nervousness (up to 33%), irritability (up to 28%), depression (up to 27%), anxiety
Common (1% to 10%): Concentration impairment, mood alteration, nightmares, aggression, emotional disorders, nervousness, decreased libido, affect lability, apathy
Uncommon (0.1% to 1%): Suicidal ideation, hallucinations
Rare (0.01% to 0.1%): Suicide, psychotic disorder
Frequency not reported: Psychosis, relapse of drug abuse/overdose, impairment of desire, sexual satisfaction affected (potentially), sexual dysfunction, mania, bipolar disorders
Postmarketing reports: Homicidal ideation[Ref]

Psychiatric side effects were among the most common reasons given for discontinuation of therapy.

Irritability/anxiety/nervousness (monotherapy: 19%; combination therapy: 33%), insomnia (monotherapy: 19%; combination therapy: 30%), depression (monotherapy: 18%; combination therapy: 20%), concentration impairment (monotherapy: 8%; combination therapy: 10%), and mood alteration (monotherapy: 3%; combination therapy: 5%) have been reported in CHC patients.

Affect lability and apathy were reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.

Impairment of desire, sexual satisfaction affected (potentially), and sexual dysfunction have been reported with peginterferon alfa-2a plus ribavirin in male patients.[Ref]

Dermatologic

Dermatologic side effects were among the most common reasons given for discontinuation of therapy.

Alopecia (monotherapy: up to 23%; combination therapy: 28%), pruritus (monotherapy: 12%; combination therapy: 19%), dermatitis (monotherapy: 8%; combination therapy: 16%), dry skin (monotherapy: 4%; combination therapy: 10%), increased sweating (monotherapy: 6%; combination therapy: 6%), rash (monotherapy: 5%; combination therapy: 8%), and eczema (monotherapy: 1%; combination therapy: 5%) have been reported in CHC patients.

Lipodystrophy acquired was reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.

Skin disorders associated with combination therapy have included lichenoid eruptions and maculopapular rashes.[Ref]

Very common (10% or more): Alopecia (up to 28%), pruritus (up to 25%), dermatitis (up to 16%), rash (up to 16%), dry skin (up to 13%)
Common (1% to 10%): Increased sweating, eczema, psoriasis, urticaria, skin disorder, photosensitivity reaction, night sweats, herpes simplex, lipodystrophy acquired
Uncommon (0.1% to 1%): Skin infection
Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme
Frequency not reported: Lichenoid eruptions, maculopapular rashes, drug-induced Sweet's syndrome
Postmarketing reports: Serious skin reactions[Ref]

Local

Injection site reactions (monotherapy: 22%; combination therapy: 23%) have been reported in CHC patients.

Skin disorders associated with combination therapy have included cutaneous necrosis at peginterferon alfa-2a injection sites.[Ref]

Very common (10% or more): Injection site reactions (up to 28%)
Frequency not reported: Cutaneous necrosis at injection sites, hyperpigmentation around/over injection sites[Ref]

Hepatic

Very common (10% or more): Elevated ALT (up to 27%)
Common (1% to 10%): Hepatic decompensation
Uncommon (0.1% to 1%): Hepatic dysfunction
Rare (0.01% to 0.1%): Hepatic failure, fatty liver, cholangitis
Frequency not reported: Elevated ALT occasionally associated with hyperbilirubinemia, exacerbations of hepatitis, hepatitis B flares, increased bilirubin[Ref]

Transient ALT elevations reported during hepatitis B therapy. ALT elevation greater than 10-fold higher than the upper limit of normal was reported in 12% and 18% during treatment and 7% and 12% posttreatment in HBeAg-negative and HBeAg-positive patients, respectively.

Hepatic decompensation has been reported in 2% of CHC patients coinfected with HIV.

The most common or important serious side effects reported during hepatitis B studies have included hepatitis B flares.[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 27%), weight decrease (up to 16%), decreased appetite (up to 16%)
Common (1% to 10%): Hyperlactacidemia/lactic acidosis
Uncommon (0.1% to 1%): Dehydration, diabetes mellitus
Rare (0.01% to 0.1%): Diabetic ketoacidosis
Frequency not reported: Elevated triglycerides, electrolyte disturbance (hypokalemia, hypocalcemia, hypophosphatemia), hyperglycemia, hypoglycemia[Ref]

Anorexia (monotherapy: up to 17%; combination therapy: 24%) and weight decrease (monotherapy: 4%; combination therapy: 10%) have been reported in CHC patients.

Hyperlactacidemia/lactic acidosis was reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.[Ref]

Respiratory

Dyspnea (monotherapy: 4%; combination therapy: 13%), cough (monotherapy: 4%; combination therapy: 10%), and exertional dyspnea (monotherapy: less than 1%; combination therapy: 4%) have been reported in CHC patients.

Pneumonia, influenza, and pharyngolaryngeal pain were reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.[Ref]

Very common (10% or more): Cough (up to 19%), dyspnea (up to 15%)
Common (1% to 10%): Pharyngitis, exertional dyspnea, epistaxis, nasopharyngitis, sinus congestion, nasal congestion, rhinitis, sore throat, bronchitis, upper respiratory tract infection, pulmonary congestion, chest tightness, pneumonia, influenza, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Wheezing
Rare (0.01% to 0.1%): Interstitial pneumonitis (including fatalities), pulmonary embolism
Frequency not reported: Lower respiratory tract infection[Ref]

Immunologic

Examples of autoimmune phenomena include hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis, immune thrombocytopenic purpura, thyroiditis, psoriasis.

Sarcoidosis was reported in a 65-year-old man at the 7th month of therapy. Most of the symptoms improved over the next 3 months after discontinuation of therapy.[Ref]

Common (1% to 10%): Development of neutralizing anti-interferon antibodies
Uncommon (0.1% to 1%): Sarcoidosis
Rare (0.01% to 0.1%): Systemic lupus erythematosus, rheumatoid arthritis
Frequency not reported: Autoimmune phenomena, development of binding antibodies to peginterferon alfa-2a, Vogt-Koyanagi-Harada disease
Postmarketing reports: Liver graft rejection, renal graft rejection

Alpha interferons:
-Frequency not reported: Development or exacerbation of autoimmune disorders (including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, systemic lupus erythematosus)[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, palpitations
Uncommon (0.1% to 1%): Hypertension
Rare (0.01% to 0.1%): Myocardial infarction, congestive heart failure, cardiomyopathy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricular tachycardia, endocarditis, vasculitis
Frequency not reported: Peripheral ischemia[Ref]

Ocular

Blurred vision (monotherapy: 4%; combination therapy: 5%) has been reported in CHC patients.[Ref]

Common (1% to 10%): Blurred vision, eye pain, eye inflammation, xerophthalmia
Uncommon (0.1% to 1%): Retinal hemorrhage
Rare (0.01% to 0.1%): Optic neuropathy, papilledema, retinal vascular disorder, retinopathy, corneal ulcers
Very rare (less than 0.01%): Vision loss
Postmarketing reports: Serous retinal detachment[Ref]

Endocrine

Hypothyroidism (monotherapy: 3%; combination therapy: 4%) has been reported in CHC patients.

Common (1% to 10%): Hypothyroidism, hyperthyroidism, clinically significant abnormal thyroid laboratory values
Uncommon (0.1% to 1%): Thyroiditis

Genitourinary

Chromaturia was reported in up to 2% of CHC patients coinfected with HIV using peginterferon alfa-2a plus ribavirin.[Ref]

Common (1% to 10%): Impotence, chromaturia[Ref]

Oncologic

Uncommon (0.1% to 1%): Hepatic neoplasm
Frequency not reported: Malignant hepatic neoplasm

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis
Frequency not reported: Anaphylactic shock

Anaphylactic shock has been reported during hepatitis B studies.

Renal

Rare (0.01% to 0.1%): Renal insufficiency

Some side effects of peginterferon alfa-2a may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Adults:
CrCl less than 30 mL/min: 135 mcg subcutaneously once a week

Comments:
-Signs/symptoms of interferon toxicity should be closely monitored.
-If severe side effects or laboratory abnormalities develop, the dose may be reduced to 90 mcg subcutaneously once a week until the side effects abate. If intolerance persists after dose adjustment, this drug should be discontinued.
-The manufacturer product information for coadministered HCV antiviral drugs should be consulted.

Pediatrics: Data not available