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Sylatron

"This week the U.S. Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).

"...

Sylatron

Sylatron Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Sylatron (peginterferon alfa-2b) is prescribed as a supplemental, post-surgical treatment for dangerous skin cancers (melanomas). Patients are cautioned that serious side effects of this medication include depression, suicidal ideation, psychosis and other neuropsychiatric disorders. Sylatron may impair human fertility. There are no adequate and well-controlled studies of Sylatron in pregnant women. Sylatron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Sylatron is administered as a subcutaneous injection. It is not known whether the components of Sylatron are excreted in human milk. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing or discontinue the Sylatron treatment, taking into account the importance of the therapy to the mother.

Our Sylatron (peginterferon alfa-2b) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sylatron in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it again.

Stop using peginterferon alfa-2b and call your doctor at once if you have:

  • vision problems;
  • fast heart rate, feeling like you might pass out;
  • fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;
  • high fever with severe stomach pain and bloody diarrhea;
  • pain or burning when you urinate;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • cough with mucus, feeling short of breath, chest pain, uneven heartbeats;
  • sudden numbness or weakness, problems with vision, speech, or balance; or
  • new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Other common side effects may include:

  • headache, joint or muscle pain;
  • nausea, dry mouth, loss of appetite, weight loss;
  • dizziness, sleep problems (insomnia), feeling mildly anxious, depressed, or irritable; or
  • pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sylatron (Peginterferon alfa-2b) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sylatron Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Flu-like symptoms (such as fever, chills, muscle/joint aches, fatigue, headache, nausea, stomach pain) may occur. If instructed to do so, taking pain/fever-reducing medications (such as acetaminophen) or injecting this medication at bedtime may help reduce some of these flu-like symptoms. Dry mouth, bad taste in mouth, increased sweating, loss of appetite, weight loss, trouble sleeping, dizziness, diarrhea, vomiting, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you experience vomiting during treatment, rinse your mouth afterwards to lessen the chance of tooth and gum problems.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: persistent sore throat or fever, easy or unusual bleeding/bruising, unusually severe fatigue, increased thirst/urination, severe stomach pain with nausea/vomiting, bloody diarrhea.

Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusually slow/fast/pounding heartbeat, vision changes (such as blurred vision, partial loss of vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sylatron (Peginterferon alfa-2b)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sylatron FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to SYLATRON in 608 patients with surgically resected, AJCC Stage III melanoma. SYLATRON was studied in an open label, multicenter, randomized, observation controlled trial. The median age of the population was 50 years with 10% of patients 65 years or older, and 42% were female. Fourteen percent of patients completed the 5 year treatment schedule.

Patients randomized to SYLATRON were to receive total doses of 48 mcg/kg (6 mcg/kg subcutaneous once weekly for 8 doses), and 780 mcg/kg (3 mcg/kg subcutaneous once weekly until disease recurrence or for up to 5 years), as tolerated. The median total dose received was 42 mcg/kg (range: 6 to 78 mcg/kg) for the first 8 doses, and 136 mcg/kg (range: 1 to 774 mcg/kg) for doses 9 to 260.

Serious adverse events were reported in 199 (33%) patients who received SYLATRON and 94 (15%) patients in the observation group.

The most common adverse reactions experienced by SYLATRON-treated patients were fatigue (94%), increased ALT (77%), increased AST (77%), pyrexia (75%), headache (70%), anorexia (69%), myalgia (68%), nausea (64%), chills (63%), and injection site reaction (62%). The most common serious adverse reactions were fatigue (7%), increased ALT (3%), increased AST (3%), and pyrexia (3%) in the SYLATRON-treated group vs. < 1% in the observation group for these reactions.

Thirty three percent of patients receiving SYLATRON discontinued treatment due to adverse reactions. The most common adverse reactions present at the time of treatment discontinuation were fatigue (27%), depression (17%), anorexia (15%), increased ALT (14%), increased AST (14%), myalgia (13%), nausea (13%), headache (13%), and pyrexia (11%). Adverse events that occurred in the clinical study at ≥ 5% incidence in the SYLATRON-treated group and with a greater incidence in patients receiving SYLATRON as compared to the observation group are presented in Table 3.

Table 4: Incidence of Adverse Reactions(*) Occurring in ≥ 5% of Melanoma Patients Treated with SYLATRON and with a Greater Incidence as Compared to Observation

Adverse Reaction SYLATRON
N=608
Observation
N=628
All Grades (%) Grade 3 and 4 (%) All Grades (%) Grade 3 and 4 (%)
Any Adverse Reaction 100 51 82 18
General Disorders and Administrative Site Conditions
Fatigue 94 16 41 1
Pyrexia 75 4 9 0
Chills 63 1 6 0
Injection Site Reaction 62 1.8 0 0
Metabolic/Laboratory
ALT or AST Increased 77 11 26 1
Blood Alkaline Phosphatase Increased 23 0 11 < 1
Weight Decreased 11 < 1 1 < 1
GGT Increased 8 4 1 < 1
Proteinuria 7 0 3 0
Anemia 6 < 1 2 < 1
Nervous System Disorders
Headache 70 4 19 1
Dysgeusia 38 0 1 0
Dizziness 35 2 11 < 1
Olfactory Nerve Disorder 23 0 1 0
Paraesthesia 21 < 1 14 < 1
Metabolism and Nutrition Disorders
Anorexia 69 3 13 0
Musculoskeletal and Connective Tissue Disorders
Myalgia 68 4 23 < 1
Arthralgia 51 3 22 1
Gastrointestinal Disorders
Nausea 64 3 11 < 1
Diarrhea 37 1 8 < 1
Vomiting 26 1 4 0
Psychiatric Disorders
Depression 59 7 24 < 1
Skin and Subcutaneous Tissue Disorders
Exfoliative Rash 36 1 4 0
Alopecia 34 0 1 0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 6 1 2 1
Cough 5 < 1 2 0
* Adverse reactions were graded using NCI CTCAE, V.2.0.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. In a clinical study conducted in patients with melanoma, the incidence of binding antibodies to peg-interferon alfa-2b was approximately 35% (50/144 patients). Among the patients who tested positive for binding antibodies, one patient developed neutralizing antibodies. The impact of antibody formation on pharmacokinetics, safety and efficacy of peg-interferon alfa-2b could not be assessed based on limited available data.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SYLATRON with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of peginterferon alfa-2b as monotherapy and in combination with ribavirin in chronic hepatitis C (CHC) patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders

pure red cell aplasia, thrombotic thrombocytopenic purpura

Ear and Labyrinth Disorders

hearing loss, vertigo, hearing impairment

Endocrine Disorders

diabetic ketoacidosis

Eye Disorders

Vogt-Koyanagi-Harada syndrome

Gastrointestinal Disorders

aphthous stomatitis, pancreatitis, colitis

Infusion Reactions

angioedema, urticaria, bronchoconstriction

Immune System Disorders

systemic lupus erythematosus, erythema multiforme, thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, and systemic lupus erythematosus

Infections

sepsis

Metabolism and Nutrition Disorders

hypertriglyceridemia

Musculoskeletal and Connective Tissue Disorders

rhabdomyolysis, myositis

Nervous System Disorders

seizures, memory loss, peripheral neuropathy, paraesthesia, migraine headache

Respiratory, Thoracic and Mediastinal Disorders

dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, sarcoidosis and pulmonary hypertension

Skin and Subcutaneous Tissue Disorders

Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis

Vascular Disorders

hypertension, hypotension, stroke

Read the entire FDA prescribing information for Sylatron (Peginterferon alfa-2b) »

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Sylatron - User Reviews

Sylatron User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sylatron sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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