Sovenor Side effects

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• Side effects of Sovenor in details
• Sovenor contraindications
• Sovenor reviews

What are the possible side effects of Sovenor?

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

Like other narcotic medicines, Sovenor can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• chest pain, fast heart rate, trouble breathing;

• weak or shallow breathing, feeling like you might pass out;

• severe constipation;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness;

• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain; or

• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common Sovenor side effects may be more likely to occur, such as:

• constipation, nausea, vomiting;

• headache, dizziness, drowsiness;

• increased sweating;

• sleep problems (insomnia); or

• pain anywhere in your body.

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.

Side effects of Sovenor in details

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

• Addiction, Abuse, and Misuse
• Respiratory and CNS Depression
• Neonatal Opioid Withdrawal Syndrome
• Adrenal Insufficiency
• Opioid Withdrawal
• Hepatitis, Hepatic Events
• Hypersensitivity Reactions
• Orthostatic Hypotension
• Elevation of Cerebrospinal Fluid Pressure
• Elevation of Intracholedochal Pressure

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 practice.

The safety of Sovenor was evaluated in 848 opioid-dependent subjects. In these studies, there was a total of 557 subjects who received at least 6 monthly SC injections of Sovenor and 138 subjects who received 12 monthly SC injections. Adverse events led to premature discontinuation in 4% of the group receiving Sovenor compared with 2% in the placebo group (13-0001, NCT02357901).

In the Phase 3 open-label study (13-0003, NCT02510014), adverse events leading to drug dose reductions were reported in 7.3% of subjects receiving Sovenor.

Table 2 shows the non-injection site-related adverse reactions (ADRs) for the groups receiving Sovenor 300/300 mg (6 doses of 300 mg SC injections) 300/100 mg (300 mg SC injections for the first two doses followed by 4 doses of 100 mg SC injections) and placebo (volume-matched ATRIGEL® delivery system subcutaneous injections) reported following administration in the 6 month, double-blind, placebo-controlled study. The systemic safety profile for Sovenor, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal Sovenor. Common adverse reactions associated with Sovenor included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Dose dependent hepatic effects observed in the Phase 3, double-blind study (13-0001, NCT02357901) included the incidence of ALT more than 3 times the upper limit of normal (> 3 × ULN) in 12.4%, 5.4%, and 4.0% of the Sovenor 300/300-mg, Sovenor 300/100-mg, and placebo groups, respectively. The incidence of AST > 3 × ULN was 11.4%, 7.9%, and 1.0%, respectively. Adverse drug reactions [by MedDRA Preferred Terms (PT)] reported in at least 2% of subjects receiving Sovenor are grouped by System Organ Class (SOC).

Table 3 shows the injection site-related adverse events reported by ≥2 subjects in the Phase 3 studies. Most injection site adverse drug reactions (ADRs) were of mild to moderate severity, with one report of severe injection site pruritus. None of the injection site reactions were serious. One reaction, an injection site ulcer, led to study treatment discontinuation.

Longer-term experience

In an interim analysis of the ongoing open-label long-term safety study (13-0003), safety was evaluated for up to 12 injections over the course of a year. Adverse events were reported for 432 of 669 subjects during the treatment period. The overall adverse event profile was similar to the double-blind trial described above.

Postmarketing Experience

The most frequently reported systemic postmarketing adverse event observed with Sovenor sublingual tablets was drug misuse or abuse. The most frequently reported systemic postmarketing adverse event with Sovenor/naloxone sublingual tablets and film was peripheral edema.

The following adverse reactions have been identified during post-approval use of Sovenor. 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.

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Sovenor.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.

What is the most important information I should know about Sovenor?

• Sovenor tablets may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Sovenor tablets. Using Sovenor tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Sovenor tablets. Sovenor tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not inject Sovenor tablets. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.
• Sovenor tablets may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Sovenor tablets.
• LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sovenor tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially decreased breathing and drowsiness.
• Sovenor tablets is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Sovenor tablets may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Sovenor tablets during pregnancy. Sovenor tablets is excreted in breast milk. Do not breast-feed while taking Sovenor tablets.

When used for long periods of time or at high doses, some people develop a need to continue taking Sovenor tablets. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Sovenor tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Sovenor contraindications

Using Sovenor improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from Sovenor. Follow all dosing instructions carefully.

Like other narcotic medicines, Sovenor can slow your breathing. Death may occur if breathing becomes too weak.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of Sovenor and similar prescription drugs.

Wear a medical alert tag or carry an ID card stating that you take Sovenor, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are being treated for narcotic addiction.

Avoid drinking alcohol, which can increase some of the side effects of Sovenor. Using too much of this medicine in addition to drinking alcohol can cause death.

Do not stop using Sovenor suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Sovenor. You may need to use less and less before you stop the medication completely.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Sovenor will affect you.

References

1. DailyMed. "BUPRENORPHINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Buprenorphine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. KEGG. "Target-based classification of drugs". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology