DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Byetta (Exenatide Injection) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Use with metformin and/or a sulfonylurea

In the three 30-week controlled trials of BYETTA add-on to metformin and/or sulfonylurea, adverse events with an incidence ≥5% (excluding hypoglycemia; see Table 3) that occurred more frequently in BYETTA-treated patients compared with placebo-treated patients are summarized in Table 4.

Table 4: Frequent Treatment-Emergent Adverse Events (≥5% Incidence and Greater Incidence With BYETTA Treatment) Excluding Hypoglycemia 1
Placebo BID
N = 483
%
All BYETTA BID
N = 963
%
Nausea1844
Vomiting413
Diarrhea613
Feeling Jittery49
Dizziness69
Headache69
Dyspepsia36

1 In three 30-week placebo-controlled clinical trials.

The adverse events associated with BYETTA generally were mild to moderate in intensity. The most frequently reported adverse event, mild to moderate nausea, occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased over time in most of the patients who initially experienced nausea. Adverse events reported in ≥1.0 to <5.0% of patients receiving BYETTA and reported more frequently than with placebo included asthenia (mostly reported as weakness), decreased appetite, gastroesophageal reflux disease, and hyperhidrosis. Patients in the extension studies at 52 weeks experienced similar types of adverse events observed in the 30-week controlled trials.

The incidence of withdrawal due to adverse events was 7% for BYETTA-treated patients and 3% for placebo-treated patients. The most common adverse events leading to withdrawal for BYETTA-treated patients were nausea (3% of patients) and vomiting (1%). For placebo-treated patients, <1% withdrew due to nausea and 0% due to vomiting.

Use with a thiazolidinedione

In the 16-week placebo-controlled study of BYETTA add-on to a thiazolidinedione, with or without metformin, the incidence and type of other adverse events observed were similar to those seen in the 30-week controlled clinical trials with metformin and/or a sulfonylurea. No serious adverse events were reported in the placebo arm. Two serious adverse events, namely chest pain (leading to withdrawal) and chronic hypersensitivity pneumonitis, were reported in the BYETTA arm.

The incidence of withdrawal due to adverse events was 16% (19/121) for BYETTA-treated patients and 2% (2/112) for placebo-treated patients. The most common adverse events leading to withdrawal for BYETTA-treated patients were nausea (9%) and vomiting (5%). For placebo-treated patients, <1% withdrew due to nausea. Chills (n=4) and injection-site reactions (n=2) occurred only in BYETTA-treated patients. The two patients who reported an injection-site reaction had high titers of anti-exenatide antibody.

Spontaneous Data

Since market introduction of BYETTA, the following additional adverse reactions have been reported. Because these events 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.

General: injection-site reactions; dysgeusia; somnolence, INR increased with concomitant warfarin use (some reports associated with bleeding).

Allergy/Hypersensitivity: generalized pruritus and/or urticaria, macular or papular rash, angioedema; rare reports of anaphylactic reaction.

Gastrointestinal: nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal distension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis.

Renal and Urinary Disorders: altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine (see PRECAUTIONS).

Immunogenicity

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-exenatide antibodies following treatment with BYETTA. In most patients who develop antibodies, antibody titers diminish over time.

In the 30-week controlled trials of BYETTA add-on to metformin and/or sulfonylurea, 38% of patients had low titer anti-exenatide antibodies at 30 weeks. For this group, the level of glycemic control (HbA1c) was generally comparable to that observed in those without antibody titers. An additional 6% of patients had higher titer antibodies at 30 weeks. In about half of this 6% (3% of the total patients given BYETTA in the 30-week controlled studies), the glycemic response to BYETTA was attenuated; the remainder had a glycemic response comparable to that of patients without antibodies.

In the 16-week trial of BYETTA add-on to thiazolidinediones, with or without metformin, 9% of patients had higher titer antibodies at 16 weeks. Compared with patients who did not develop antibodies to BYETTA, on average the glycemic response in patients with higher titer antibodies was attenuated.

The patient’s glycemic response to BYETTA should be monitored. If there is worsening glycemic control or failure to achieve targeted glycemic control, alternative antidiabetic therapy should be considered.



REPORTS OF SUSPECTED BYETTA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Byetta. The information is not vetted and should not be considered as verified clinical evidence.

Possible Byetta side effects / adverse reactions in 56 year old male

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 56 year old male weighing 112.0 kg (246.4 pounds)

Reactions: Weight Decreased, Pancreatitis, Hypertriglyceridaemia

Suspect drug(s):
Byetta
    Dosage: 10 ug, bid
    Start date: 2010-11-12
    End date: 2011-07-28

Byetta
    Dosage: 5 ug, bid
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-10-15
    End date: 2010-11-11

Other drugs received by patient: Aspirin; Metformin HCL; Simvastatin; Metoprolol Succinate; Pantoprazole; Marcumar; Diovan; Metoprolol Succinate; Pravastatin; Diovan; Diclo-Divido



Possible Byetta side effects / adverse reactions in 63 year old male

Reported by a consumer/non-health professional from France on 2011-10-03

Patient: 63 year old male

Reactions: Syncope

Suspect drug(s):
Byetta



Possible Byetta side effects / adverse reactions in 55 year old female

Reported by a physician from United States on 2011-10-03

Patient: 55 year old female

Reactions: Weight Decreased, Fluid Intake Reduced, Renal Failure Acute, Decreased Appetite

Suspect drug(s):
Byetta



See index of all Byetta side effect reports >>

Drug label data at the top of this Page last updated: 2007-09-27

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012