Sovenor Uses

• Sovenor indications
• Uses of Sovenor in details
• Sovenor description
• Sovenor dosage
• Sovenor interactions
• Sovenor side effects
• Sovenor contraindications

What is Sovenor?

Sovenor is an opioid medication, sometimes called a narcotic.

This medication guide provides information about the Sovenor brand of Sovenor injection. Sovenor is another brand of Sovenor injection that is used to treat moderate to severe pain.

Sovenor is used to treat opioid addiction. Sovenor is not for use as a pain medication.

Sovenor is given to people who have started addiction treatment with an oral form of Sovenor placed under the tongue or inside the cheek (such as Suboxone or Sovenor).

Sovenor is available only in a certified healthcare setting under a special program. You will not be able to give yourself this medicine.

Sovenor may also be used for purposes not listed in this medication guide.

Sovenor indications

Sovenor is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal Sovenor-containing product (i.e., doses of no more than 8 mg per day of Sovenor or Suboxone sublingual tablet equivalent or generic equivalent).

Sovenor should be used as part of a complete treatment program to include counseling and psychosocial support.

Sovenor is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on Sovenor 8 mg per day or less of a Sovenor or Suboxone sublingual tablet equivalent or generic equivalent.

How should I use Sovenor?

Use Sovenor patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sovenor patch comes with an extra patient information sheet called a Medication Guide. It also comes with an additional patient information leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Sovenor patch refilled.
• Sovenor patch is for external use only.
• Apply Sovenor patch right away after removing it from the sealed package. Do not use Sovenor patch if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.
• Sovenor patch is only to be used on intact, clean, dry skin. Do not apply Sovenor patch to broken, damaged, or inflamed skin.
• The application site should be hairless or nearly hairless. If you have no hairless areas, clip the hair at the application site; do NOT shave it. If the application site must be cleaned, clean the site with clear water only. Do NOT clean the area with soap, alcohol, lotion, oil, or other cleansers because the risk of Sovenor patch's side effects may be increased. Allow the skin to dry before you apply the patch.
• Apply the patch to the upper outer arm, upper chest, upper back, or the side of your chest on either side of your body. Do not apply a new patch to the same skin area for at least 21 days. Do not wear more than 1 patch at a time unless your doctor tells you otherwise.
• Press the patch firmly in place with the palm of your hand for about 15 seconds. Do not rub the patch. Make sure the contact is complete, especially around the edges. Wash your hands after you apply or handle a patch.
• If the patch does not stick, you may tape only the edges with first-aid tape or cover the patch with a special type of clear adhesive film dressing (eg, Bioclusive, Tegaderm). Do not cover the patch with any other bandage or tape. Ask your doctor or pharmacist about the kinds of dressings that should be used.
• If the patch falls off before 7 days have passed, do NOT re-apply it. Apply a new patch to a different skin site.
• A patch may be worn continuously for 1 week (exactly 7 days) or as directed by your doctor. After removing the old patch, a new patch may be applied to a different skin site.
• After removing the used patch, if a patch falls off before 7 days have passed, or if unused patches remain that are no longer needed, follow the disposal instructions listed in the additional patient leaflet with instructions for use that comes with Sovenor patch. Contact your pharmacist if you have any questions about how to dispose of Sovenor patch.
• Do not suddenly stop using Sovenor patch. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Sovenor patch, your doctor will gradually lower your dose.
• If you forget to change your patch on the day it is due, change the patch as soon as you remember. Do NOT double your dose to catch up.

Ask your health care provider any questions you may have about how to use Sovenor patch.

Uses of Sovenor in details

Use: Labeled Indications

Opioid use disorder:

Extended-release injection: Maintenance treatment of moderate to severe opioid use disorder in patients who have initiated treatment with 8 to 24 mg of a transmucosal Sovenor-containing product, followed by dose adjustment for a minimum of 7 days.

Subdermal implant: Maintenance treatment of opioid use disorder in patients who have achieved and sustained prolonged clinical stability on low to moderate doses (≤8 mg/day) of a transmucosal Sovenor-containing product for 3 months or longer with no need for supplemental dosing or adjustments

Sublingual tablet: Medically supervised withdrawal and maintenance treatment of opioid use disorder.

Limitations of use: Sovenor should be used as part of a complete treatment program to include counseling and psychosocial support.

Pain management:

Buccal film, transdermal patch: Management of pain severe enough to require around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Immediate-release injection: Management of pain severe enough to require an opioid analgesic and for which treatments are inadequate

Limitations of use: Reserve Sovenor for use in patients for whom alternative treatment options (eg, nonopioid analgesics, opioid combination products, immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Sovenor buccal film and transdermal patch are not indicated as an as needed analgesic.

Off Label Uses

Opioid withdrawal in heroin-dependent hospitalized patients (immediate-release injection)

Data from a limited number of patients studied who received Sovenor parenterally for opioid withdrawal during hospitalization for an acute medical problem suggests that Sovenor is safe when used in this setting; Additional data may be necessary to further define the role of Sovenor in the management of postoperative pain as a perineural adjunct.

Sovenor description

Sovenor transdermal patch is available in three strengths: Sovenor 5 mg contains 5 mg Sovenor in a drug-containing matrix that releases a nominal 5 micrograms of Sovenor per hour over 7 days.

Sovenor 10 mg contains 10 mg Sovenor in a drug-containing matrix that releases a nominal 10 micrograms of Sovenor per hour over 7 days.

Sovenor 20 mg contains 20 mg Sovenor in a drug-containing matrix that releases a nominal 20 micrograms of Sovenor per hour over 7 days.

Sovenor is a rectangular or square, transdermal patch consisting of a protective liner and functional layers including a Sovenor-containing adhesive matrix.

Excipients/Inactive Ingredients: Levulinic acid, oleyl oleate, povidone (PVP), polyacrylate (dry solids), polyethylene terephthalate (PET).

Sovenor dosage

Dosage and Titration: The lowest Sovenor 5 mg should be used as the initial dose in all patients.

During initiation, titration, and treatment with Sovenor, patients may continue their existing NSAID or acetaminophen regimen as needed.

The dose of Sovenor should not be increased at less than 3-day intervals when steady-state levels are attained. Changes in Sovenor dosage may be individually titrated based on the need for supplemental PRN analgesia and the patient's analgesic response to Sovenor.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches be applied at the same time, regardless of patch strength.

Titration should continue every 3-7 days until adequate analgesia is achieved.

If adequate pain control cannot be achieved with Sovenor, therapy should be discontinued and the patient converted to an appropriate analgesic regimen as determined by a physician.

Discontinuation: After removal of Sovenor, plasma concentrations decrease gradually. This should be considered when therapy with Sovenor is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of Sovenor.

Conversion From Opioids: Sovenor can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose Sovenor 5 mg and continue taking short-acting supplemental analgesics during titration, as required.

Children: The safety and efficacy of Sovenor in patients under 18 years of age has not been established.

Renal Impairment: No special dose adjustment of Sovenor is necessary in patients with renal impairment.

Hepatic Impairment: There is no need for dosage adjustment when using Sovenor in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment may accumulate Sovenor during Sovenor treatment. Consideration of alternate therapy should be given, and Sovenor should be used with caution, if at all, in such patients.

Elderly: No dosage adjustment of Sovenor is required in elderly patients.

Administration: Sovenor should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. Sovenor should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped with scissors, not shaven.

Application sites should be rotated whenever a patch is replaced or added. Application sites should be re-used at no less than 3-week intervals.

If the application site must be cleaned, it should be done with clear water only. Soaps, alcohol, oils, lotions, or abrasive devices should not be used. The skin must be dry before the transdermal patch is applied.

Sovenor should be worn continuously for 7 days. Sovenor should be pressed firmly in place at the application site, making sure contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape. If a transdermal patch falls off, a new one should be applied. Bathing, showering, or swimming should not affect the patch. While wearing Sovenor, patients should be advised to avoid exposing the Sovenor site to direct external heat sources such as heating pads, electric blankets, heat lamps, etc., as an increase in absorption of Sovenor may occur. The effects of the use of Sovenor while in hot tubs and saunas have not been studied.

Patch Application: Applying the Patch: Step 1: Each patch is sealed in a pouch. Just before use, open the pouch by tearing where indicated. Take out the patch.

Step 2: The sticky side of the patch is covered with a silvery protective foil. Carefully peel off half the foil. Try not to touch the sticky part of the patch.

Step 3: Stick the patch onto the chosen area of the skin and remove the remaining foil.

Step 4: Press the patch against the skin with the palm of the hand and count slowly to 30. Make sure that the whole patch is in contact with the skin, especially at the edges.

Step 5: Find a calendar that will help to remember to change the patch every 7th day. Mark the day when the first patch was put on and make a note of the time of day.

Wearing the Patch: Sovenor should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. Application sites should be re-used at no less than 3-week (21 days) intervals.

If a transdermal patch falls off before it needs changing, a new patch should be applied.

Changing the Patch: Take the old patch off.

Fold it in half with the sticky side inwards. Put the used patch into its original pouch. Then put the pouch in the bin used for the household rubbish. Even used patches contain some active medicine that may harm children or animals, so make sure the used patches are always kept well away from them. Throw it away carefully, out of the reach and sight of children.

Stick a new patch on a different appropriate skin site. The patient should not apply a new patch to the same site for the following 3-4 weeks.

Mark the day and time of application on the calendar.

Remember to change the patch at the same time of day each time.

Sovenor interactions

See also:
What other drugs will affect Sovenor?

Drug interactions common to other potent opioid analgesics also may occur with Sovenor (Sovenor). Particular care should be taken when Sovenor (Sovenor) is used in combination with central nervous system depressant drugs. Although specific information is not presently available, caution should be exercised when Sovenor (Sovenor) is used in combination with MAO inhibitors. There have been reports of respiratory and cardiovascular collapse in patients who received therapeutic doses of diazepam and Sovenor (Sovenor). A suspected interaction between Sovenor (Sovenor) and phenprocoumon resulting in purpura has been reported.

CYP3A4 Inhibitors: Since the metabolism of Sovenor is mediated by the CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of Sovenor. Thus patients coadministered with inhibitors of CYP3A4 such as macrolide antibiotics (e.g., erythromycin), azole antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritanovir) while receiving Sovenor (Sovenor) should be carefully monitored and dosage adjustment made if warranted.

CYP3A4 Inducers: Cytochrome P450 inducers, such as rifampin, carbamazepine, and phenytoin, induce metabolism and as such may cause increased clearance of Sovenor. Caution is advised when administering Sovenor (Sovenor) to patients receiving these medications and if necessary dose adjustments should be considered

Sovenor side effects

See also:
What are the possible side effects of Sovenor?

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.

Sovenor contraindications

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

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.

Active ingredient matches for Sovenor:

Buprenorphine in Malaysia, South Africa.

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. PubChem. "buprenorphine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "buprenorphine". http://www.drugbank.ca/drugs/DB00921 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology