"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Somavert Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Somavert (pegvisomant) is used for the treatment of acromegaly (a growth disorder caused by too much growth hormone). It is a manufactured protein similar to human growth hormone (GH). Common side effects include lumps under the skin if the same injection site is used often. To reduce the chance of this side effect, change the injection site daily. Redness/swelling at the injection site, pain, diarrhea, or nausea may also occur.
A loading dose of 40 mg of Somavert should be administered subcutaneously under physician supervision. The patient should then be instructed to begin daily subcutaneous injections of 10 mg. Somavert may interact with insulin, oral diabetes medicines, or narcotics. Tell your doctor all medications and supplements you use. During pregnancy, Somavert should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Somavert (pegvisomant) 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.
Somavert in Detail - Patient Information: Side Effects
If you experience any of the following uncommon but serious side effects, stop taking pegvisomant and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
- liver problems (may be detected by blood tests or symptoms such as yellowing of the skin or eyes, vomiting, abdominal pain, unusual fatigue, loss of appetite, itching, clay-colored stools, or dark urine).
Other, less serious side effects may be more likely to occur. Continue to take pegvisomant and talk to your doctor if you experience
- discomfort at the injection site;
- "flu-like" symptoms
- nausea or diarrhea;
- dizziness; or
- water retention or slight weight gain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Somavert (Pegvisomant) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Somavert Overview - Patient Information: Side Effects
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.
Get medical help right away if any of these rare but serious side effects occur: signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, unusual tiredness, yellowing eyes/skin, dark urine).
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 Somavert (Pegvisomant)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Somavert FDA Prescribing Information: Side Effects
Clinically significant adverse reactions that appear in other section of the labeling include:
- Hypoglycemia associated with GH lowering in patients with Diabetes Mellitus [see WARNINGS AND PRECAUTIONS]
- Liver test elevations [see WARNINGS AND PRECAUTIONS]
- Cross-reactivity with GH assay [see WARNINGS AND PRECAUTIONS]
- Lipohypertrophy [see WARNINGS AND PRECAUTIONS]
- Systemic hypersensitivity [see WARNINGS AND PRECAUTIONS]
Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies. One patient was rechallenged with SOMAVERT, and the recurrence of elevated transaminase levels suggested a probable causal relationship between administration of the drug and the elevation in liver enzymes. A liver biopsy performed on the second patient was consistent with chronic hepatitis of unknown etiology. In both patients, the transaminase elevations normalized after discontinuation of the drug.
Elevations in ALT and AST levels were not associated with increased levels of TBIL and ALP, with the exception of two patients with minimal associated increases in ALP levels (i.e., less than 3 times ULN). The transaminase elevations did not appear to be related to the dose of SOMAVERT administered, generally occurred within 4 to 12 weeks of initiation of therapy, and were not associated with any identifiable biochemical, phenotypic, or genetic predictors.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
In a 12-week randomized, placebo-controlled, double-blind, fixed-dose study of SOMAVERT in subjects with acromegaly, 32 subjects received placebo and 80 subjects received SOMAVERT once daily [see Clinical Studies]. A total of 108 subjects (30 placebo, 78 Somavert) completed 12 weeks of study treatment.
Overall, eight patients with acromegaly (5.3%) withdrew from pre-marketing clinical studies because of adverse events, including two patients with marked transaminase elevations, one patient with lipohypertrophy at the injection sites, and one patient with substantial weight gain. Most adverse events did not appear to be dose-dependent. Table 3 shows the incidence of adverse events that were reported in at least two patients treated with SOMAVERT and at frequencies greater than placebo during the 12-week, placebo-controlled study.
Table 3: Adverse Reactions in in a 12-week
Placebo-Controlled Study in Patients with Acromegaly*
|Infection†||2 (6%)||6 (23%)||0||0|
|Pain||2 (6%)||2 (8%)||1 (4%)||4 (14%)|
|Nausea||1 (3%)||0||2 (8%)||4 (14%)|
|Diarrhea||1 (3%)||1 (4%)||0||4 (14%)|
|Abnormal liver function tests||1 (3%)||3 (12%)||1 (4%)||1 (4%)|
|Flu syndrome||0||1 (4%)||3 (12%)||2 (7%)|
|Injection site reaction||0||2 (8%)||1 (4%)||3 (11%)|
|Dizziness||2 (6%)||2 (8%)||1 (4%)||1 (4%)|
|Accidental injury||1 (3%)||2 (8%)||1 (4%)||0|
|Back pain||1 (3%)||2 (8%)||0||1 (4%)|
|Sinusitis||1 (3%)||2 (8%)||0||1 (4%)|
|Chest pain||0||1 (4%)||2 (8%)||0|
|Peripheral edema||0||2 (8%)||0||1 (4%)|
|Paresthesia||2 (6%)||0||0||2 (7%)|
|* Table includes only those events that were reported in
at least 2 patients and at a higher incidence in patients treated with SOMAVERT
than in patients treated with placebo.
† The 6 events coded as “infection” in the group treated with SOMAVERT 10 mg were reported as cold symptoms (3), upper respiratory infection (1), blister (1), and ear infection (1).The 2 events in the placebo group were reported as cold symptoms (1) and chest infection (1).
In pre-marketing clinical studies, approximately 17% of the SOMAVERT-treated patients developed low titer, non-neutralizing anti-GH antibodies. Although the presence of these antibodies did not appear to impact the efficacy of SOMAVERT, the long-term clinical significance of these antibodies is not known. No assay for anti-pegvisomant antibodies is commercially available for patients receiving SOMAVERT.
The data above reflect the percentage of patients whose test results were considered positive for antibodies to SOMAVERT. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SOMAVERT with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during post-approval use of SOMAVERT. 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.
Systemic hypersensitivity reactions including anaphylactic reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post-marketing use. Some patients required hospitalization. Symptoms did not re-occur in all patients after re-challenge [see WARNINGS AND PRECAUTIONS].
Registry of Patients with Acromegaly Treated with SOMAVERT
ACROSTUDY is an international observational registry that captures long term safety data in patients with acromegaly treated with SOMAVERT, as used in clinical practice. Treatment dose and schedule were at the discretion of each treating physician. Although safety monitoring as per the recommended schedule was mandatory, not all assessments were performed at all time points for every patient. Because of this, comparison of rates of adverse events to those in the original clinical trial is not appropriate. In an interim report, there were 1288 patients enrolled (mean duration of treatment 3.7 years).
At the start of SOMAVERT treatment 648 patients were on SOMAVERT monotherapy for acromegaly. Of the 454 patients who had a normal AST and ALT at baseline, 4 patients had elevated tests > 3 times ULN, two of whom had elevated tests > 5 times ULN.
Lipohypertrophy was reported in 6 (0.5%) patients.
MRIs were compared to any previous ones, and a change in tumor volume was reported as significant locally only if the diameter increased by more than 3 mm for microadenomas or volume increased by more than 20% for macroadenomas. All MRI changes considered significant at the local reading were reanalyzed centrally. Of the 747 patients who had a MRI reported at baseline and at least once during follow up in the study, 51 (7%) were reported to have an increase by local MRI. Of these, 16 patients (2%) had confirmation of this increase, 6 patients had a decrease, 12 had “no change”; there was 1 with insufficient data and 16 patients did not have a central MRI reading.
Read the entire FDA prescribing information for Somavert (Pegvisomant) »
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