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All product information provided is intended for U.S. healthcare professionals only. These products may not be available in countries outside the U.S. or may be available under a different trademark; in different strengths; or for different indications. Countries outside the U.S. may have different regulatory requirements that would call for different information to be available.

Key commercial products in the United States include:

Vivitrol Consta Prescribing Information Product Website

Important Safety Information for VIVITROL® (naltrexone for extended-release injectable suspension)

INDICATIONS

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. VIVITROL is also indicated for the prevention of relapse to opioid dependence, following opioid detoxification. Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid-free at the time of initial VIVITROL administration. VIVITROL should be part of a comprehensive management program that includes psychosocial support.

CONTRAINDICATIONS

VIVITROL is contraindicated in patients with acute hepatitis or liver failure; patients receiving opioid analgesics; patients with current physiologic opioid dependence; patients in acute opioid withdrawal; patients who have failed the naloxone challenge test or have a positive urine screen for opioids; and patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other components of the diluent.

WARNINGS AND PRECAUTIONS

  • Vulnerability to Opioid Overdose: After opioid detoxification, patients are likely to have reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade dissipates, the patient is at risk for potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if they use opioids at previously-tolerated doses. Patients, family members, and other healthcare providers should be alerted that patients may be more sensitive to opioids, even at lower doses, after VIVITROL treatment is discontinued, especially at the end of a dosing interval (i.e., near the end of the month that VIVITROL was administered), or after a dose of VIVITROL is missed and are at risk of overdose. The VIVITROL blockade is surmountable and any attempt by a patient to overcome it by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.
  • Injection Site Reactions: VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using one of the customized needles provided in the carton. Because needle length may not be adequate due to body habitus, every patient should be assessed prior to each injection to assure that selected needle length is adequate for IM administration. VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
  • Precipitation of Opioid Withdrawal: When withdrawal has been precipitated abruptly by the administration of VIVITROL to an opioid-dependent patient, there have been cases in which the resulting withdrawal syndrome has been severe enough to require hospitalization, and in some cases, management in the intensive care unit. Therefore, to prevent precipitated withdrawal or exacerbation of a pre-existing subclinical withdrawal, patients (including those being treated for alcohol dependence) should be opioid-free (including tramadol) for a minimum of 7-10 days before starting VIVITROL treatment. An opioid-free interval is recommended for patients previously dependent on short-acting opioids. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. If a more rapid transition from agonist to antagonist therapy is deemed necessary or appropriate, monitor the patient closely in a medical setting where precipitated withdrawal can be properly treated. Manage withdrawal symptomatically with non-opioid medications.

There is no completely reliable method for determining whether a patient is opioid-free. A naloxone challenge test may be helpful; however, patients have experienced precipitated withdrawal despite a negative urine toxicology screen or tolerating a naloxone challenge test (when transitioning from buprenorphine treatment).

Patients should be made aware of the risks associated with precipitated withdrawal and encouraged to give an accurate account of last opioid use. Patients treated for alcohol dependence with VIVITROL should also be assessed for underlying opioid dependence and for any recent use of opioids prior to initiation of treatment with VIVITROL. Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

  • Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL treatment during the clinical development program and in the postmarketing period. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.
  • Depression and Suicidality: Alcohol- and opioid-dependent patients, including those taking VIVITROL, should be monitored for depression or suicidal thoughts.
  • When Reversal of VIVITROL Blockade is Required for Pain Management: For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by trained personnel in a setting equipped for cardiopulmonary resuscitation.
  • Eosinophilic Pneumonia: Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia.
  • Hypersensitivity Reactions: Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
  • Intramuscular Injections: As with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

ADVERSE EVENTS

The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients also include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For patient and physician information, please visit http://www.vivitrol.com/ or call 1-800-VIVITROL (1-800-848-4876).

VIVITROL Full U.S. Prescribing Information

VIVITROL Medication Guide

Bydureon Prescribing Information Product Website

Important Safety Information for BYDUREON® (exenatide extended-release for injectable suspension)

WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with BYDUREON. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

See full prescribing information for complete boxed warning.

Indications

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

  • Because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans, prescribe only to patients for whom potential benefits are considered to outweigh potential risk.
  • Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
  • Not a substitute for insulin, should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and cannot be recommended for use with insulin.
  • BYDUREON and BYETTA® (exenatide) injection both contain the same active ingredient, exenatide, and should not be used together.
  • Exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYDUREON; consider other antidiabetic therapies for these patients.

Contraindications

  • BYDUREON is contraindicated in patients with known prior severe hypersensitivity reactions to exenatide or to any of the product components.

Warnings and Precautions

  • Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation of BYDUREON, observe patients carefully for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYDUREON should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
  • Increased risk of hypoglycemia when used in combination with glucose-independent insulin secretagogues (eg, sulfonylureas). Clinicians may consider reducing the sulfonylurea (SFU) dose.
  • Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or moderate renal failure. Postmarketing reports of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
  • Not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
  • Patients may develop antibodies to exenatide. In 5 registration trials, attenuated glycemic response was associated in 6% of BYDUREON-treated patients with antibody formation. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
  • Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON and other suspect medications and promptly seek medical advice.
  • No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.

Withdrawals

  • In 5 comparator-controlled, 24- to 30-week BYDUREON trials, the incidence of withdrawal due to adverse events was 4.9% for BYDUREON, 4.9% for BYETTA, and 2.0% for other comparators. The most common adverse reactions leading to withdrawal for BYDUREON, BYETTA, and comparators respectively were: nausea (0.5%,1.5%, 0.3%); injection-site nodule (0.5%, 0.0%, 0.0%); diarrhea (0.3%, 0.4%, 0.3%); injection-site reaction (0.2%, 0.0%, 0.0%); and headache (0.2%, 0.0%, 0.0%). One percent of BYDUREON patients withdrew due to injection-site adverse reactions.

Adverse Reactions (≥5%)

  • BYDUREON vs BYETTA: 24-week trial, nausea (14% vs 35%), diarrhea (9.3% vs 4.1%), injection-site erythema (5.4% vs 2.4%); 30-week trial, nausea (27% vs 33.8%), diarrhea (16.2% vs 12.4%), vomiting (10.8% vs 18.6%), injection-site pruritus (18.2% vs 1.4%), constipation (10.1% vs 6.2%), gastroenteritis viral (8.8% vs 5.5%), gastroesophageal reflux disease (7.4% vs 4.1%), dyspepsia (7.4% vs 2.1%), injection-site erythema (7.4% vs 0.0%), fatigue (6.1% vs 3.4%), headache (6.1% vs 4.8%), injection-site hematoma (5.4% vs 11.0%).
  • BYDUREON vs titrated insulin glargine: nausea (12.9% vs 1.3%), headache (9.9% vs 7.6%), diarrhea (9.4% vs 4.0%), injection-site nodule (6.0% vs 0.0%).
  • Combination trial vs sitagliptin and pioglitazone: nausea (24.4% vs 9.6% and 4.8%), diarrhea (20.0% vs 9.6% and 7.3%), vomiting (11.3% vs 2.4% and 3.0%), headache (9.4% vs 9.0% and 5.5%), constipation (6.3% vs 3.6% and 1.2%), fatigue (5.6% vs 0.6% and 3.0%), dyspepsia (5.0% vs 3.6% and 2.4%), decreased appetite (5.0% vs 1.2% and 0.0%), injection-site pruritus (5.0% vs 4.8% and 1.2%).
  • Monotherapy trial vs sitagliptin, pioglitazone, and metformin: nausea (11.3% vs 3.7%, 4.3%, and 6.9%), diarrhea (10.9% vs 5.5%, 3.7%, and 12.6%), injection-site nodule (10.5% vs 6.7%, 3.7%, and 10.2%), constipation (8.5% vs 2.5%, 1.8%, and 3.3%), headache (8.1% vs 9.2%, 8.0%, and 12.2%), dyspepsia (7.3% vs 1.8%, 4.9%, and 3.3%).
  • Injection-site reactions were observed more frequently in BYDUREON-treated patients (17.1%) vs patients treated with BYETTA (12.7%), titrated insulin glargine (1.8%), or placebo injection (6.4%-13.0%). Injection-site reactions were observed in 14.2% of antibody-positive patients vs 3.1% of antibody-negative patients, with higher incidence in those with higher-titer antibodies. BYETTA-treated patients had similar incidence between antibody-positive and antibody-negative patients (5.8% vs 7.0%). Small, asymptomatic, subcutaneous injection-site nodules are seen with the use of BYDUREON.

Hypoglycemia

  • No major hypoglycemia was reported for BYDUREON- or comparator-treated patients in five 24- to 30-week trials. Minor hypoglycemia incidences for BYDUREON vs comparator-treated patients were as follows: 24-week trial vs BYETTA: with SFU, 12.5% vs 11.8%; without SFU, 0.0% for both; 30-week trial vs BYETTA: with SFU, 14.5% vs 15.4%; without SFU, 0.0% vs 1.1%; monotherapy trial vs sitagliptin, pioglitazone, and metformin: 2.0% vs 0.0% (all comparators); combination trial vs sitagliptin and pioglitazone: 1.3% vs 3.0% and 1.2%; vs titrated insulin glargine, with SFU, 20.0% vs 43.9%; without SFU, 3.7% vs 19.1%.

Drug Interactions

  • BYDUREON slows gastric emptying and can reduce the rate of absorption of orally administered drugs. Use with caution with oral medications.
  • Postmarketing reports of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYDUREON.

Use in Specific Populations

  • Based on animal data, BYDUREON may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Caution should be exercised when administered to a nursing woman.
  • Use in pediatric patients is not recommended as safety and effectiveness have not been established.

For complete safety profile and other important prescribing considerations, see the Prescribing Information and Medication Guide.

This page is intended for U.S. healthcare professionals only.