Bunogesic Uses

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

What is Bunogesic?

Bunogesic is an opioid medication, sometimes called a narcotic.

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

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

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

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

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

Bunogesic indications

Bunogesic 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 Bunogesic-containing product (i.e., doses of no more than 8 mg per day of Bunogesic or Suboxone sublingual tablet equivalent or generic equivalent).

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

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

How should I use Bunogesic?

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

• Bunogesic 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 Bunogesic patch refilled.
• Bunogesic patch is for external use only.
• Apply Bunogesic patch right away after removing it from the sealed package. Do not use Bunogesic patch if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.
• Bunogesic patch is only to be used on intact, clean, dry skin. Do not apply Bunogesic 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 Bunogesic 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 Bunogesic patch. Contact your pharmacist if you have any questions about how to dispose of Bunogesic patch.
• Do not suddenly stop using Bunogesic patch. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Bunogesic 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 Bunogesic patch.

Uses of Bunogesic 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 Bunogesic-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 Bunogesic-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: Bunogesic 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 Bunogesic 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. Bunogesic 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 Bunogesic parenterally for opioid withdrawal during hospitalization for an acute medical problem suggests that Bunogesic is safe when used in this setting; Additional data may be necessary to further define the role of Bunogesic in the management of postoperative pain as a perineural adjunct.

Bunogesic description

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

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

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

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

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

Bunogesic dosage

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

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

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

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 Bunogesic, therapy should be discontinued and the patient converted to an appropriate analgesic regimen as determined by a physician.

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

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

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

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

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

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

Administration: Bunogesic should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. Bunogesic 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.

Bunogesic should be worn continuously for 7 days. Bunogesic 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 Bunogesic, patients should be advised to avoid exposing the Bunogesic site to direct external heat sources such as heating pads, electric blankets, heat lamps, etc., as an increase in absorption of Bunogesic may occur. The effects of the use of Bunogesic 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: Bunogesic 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.

Bunogesic interactions

See also:
What other drugs will affect Bunogesic?

Drug interactions common to other potent opioid analgesics also may occur with Bunogesic (Bunogesic). Particular care should be taken when Bunogesic (Bunogesic) is used in combination with central nervous system depressant drugs. Although specific information is not presently available, caution should be exercised when Bunogesic (Bunogesic) 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 Bunogesic (Bunogesic). A suspected interaction between Bunogesic (Bunogesic) and phenprocoumon resulting in purpura has been reported.

CYP3A4 Inhibitors: Since the metabolism of Bunogesic is mediated by the CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of Bunogesic. 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 Bunogesic (Bunogesic) 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 Bunogesic. Caution is advised when administering Bunogesic (Bunogesic) to patients receiving these medications and if necessary dose adjustments should be considered

Bunogesic side effects

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

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 Bunogesic 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 Bunogesic and 138 subjects who received 12 monthly SC injections. Adverse events led to premature discontinuation in 4% of the group receiving Bunogesic 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 Bunogesic.

Table 2 shows the non-injection site-related adverse reactions (ADRs) for the groups receiving Bunogesic 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 Bunogesic, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal Bunogesic. Common adverse reactions associated with Bunogesic 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 Bunogesic 300/300-mg, Bunogesic 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 Bunogesic 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 Bunogesic sublingual tablets was drug misuse or abuse. The most frequently reported systemic postmarketing adverse event with Bunogesic/naloxone sublingual tablets and film was peripheral edema.

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

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

Bunogesic contraindications

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

Using Bunogesic 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 Bunogesic. Follow all dosing instructions carefully.

Like other narcotic medicines, Bunogesic 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 Bunogesic and similar prescription drugs.

Wear a medical alert tag or carry an ID card stating that you take Bunogesic, 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 Bunogesic. Using too much of this medicine in addition to drinking alcohol can cause death.

Do not stop using Bunogesic suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Bunogesic. 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 Bunogesic will affect you.

Active ingredient matches for Bunogesic:

Buprenorphine in India.

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