SYNDROS

SYNDROS- dronabinol solution
Insys Therapeutics, Inc.

1 INDICATIONS AND USAGE

SYNDROS is indicated in adults for the treatment of:

  • anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS).
  • nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Oral Administration

  • Always use the enclosed calibrated oral dosing syringe when administering SYNDROS to ensure the dose is measured and administered accurately.
  • The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe.
  • Take each dose of SYNDROS with a full glass of water (6 to 8 ounces).
  • For information on dosing SYNDROS with regard to meals, see Dosage and Administration 2.2 and 2.3.

Administration via Feeding Tube (silicone only, greater than or equal to 14 French)

SYNDROS can be administered via enteral feeding tubes that are manufactured using silicone, size greater than or equal to 14 French, such as Naso-Gastric (NG), Gastrostomy Tube (G-tube), Percutaneous Endoscopic Gastrostomy tube (PEG-tube) and Gastro-Jejunostomy tube (GJ-tube). Do not use tubes manufactured of polyurethane.

  1. Draw up the prescribed dose with the calibrated dosing syringe packaged with SYNDROS.
  2. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe.
  3. Using the calibrated dosing syringe, administer the dose via the feeding tube.
  4. Using a catheter-tip syringe, flush the feeding tube with 30 mL of water.

2.2 Anorexia Associated with Weight Loss in Adult Patients with AIDS

Starting Dosage

The recommended adult starting dosage of SYNDROS is 2.1 mg orally twice daily, one hour before lunch and one hour before dinner.

In elderly patients, or patients unable to tolerate 2.1 mg twice daily, consider initiating SYNDROS at 2.1 mg once daily one hour before dinner or at bedtime to reduce the risk of central nervous system (CNS) symptoms [see Use in Specific Populations (8.5) ].

Dosing later in the day may reduce the frequency of Central Nervous System (CNS) adverse reactions. CNS adverse reactions are dose-related [see Warnings and Precautions (5.1)] ; therefore, monitor patients and reduce the dosage as needed. If CNS adverse reactions of feeling high, dizziness, confusion, and somnolence occur, they usually resolve in 1 to 3 days and usually do not require dosage reduction. If CNS adverse reactions are severe or persistent, reduce the dosage to 2.1 mg once daily one hour before dinner or in the evening at bedtime.

Dosage Titration

  • If tolerated and further therapeutic effect is desired, the dosage may be increased gradually to 2.1 mg one hour before lunch and 4.2 mg one hour before dinner. Increase the dose of SYNDROS gradually in order to reduce the frequency of dose-related adverse reactions [see Warnings and Precautions (5.1)].
  • Most patients respond to 2.1 mg twice daily, but the dose may be further increased to 4.2 mg one hour before lunch and 4.2 mg one hour before dinner, as tolerated to achieve a therapeutic effect.
  • Maximum Dosage: 8.4 mg twice daily.

2.3 Nausea and Vomiting Associated with Cancer Chemotherapy in Adult Patients Who Failed Conventional Antiemetics

Starting Dosage

The recommended starting dosage of SYNDROS is 4.2 mg/m2 orally administered 1 to 3 hours prior to chemotherapy and then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day.

  • Calculate the starting dose by following the steps below:
    • Starting dose (mg) = Patient body surface area (BSA) in m2 multiplied by 4.2 mg/m2
    • Round dose to the nearest 0.1 mg increment
    • Convert from milligrams (mg) to milliliters (mL):
      • Starting dose (mg) rounded to the nearest 0.1 mg increment divided by 5 = Starting dose in milliliters (mL)
    • To correspond with the calibrated oral dosing syringe, the dose may need to be rounded to the nearest 0.1 mL increment.

In elderly patients, consider initiating SYNDROS at 2.1 mg/m2 once daily 1 to 3 hours prior to chemotherapy to reduce the risk of CNS symptoms [see Use in Specific Populations (8.5)].

Because food delays the absorption of SYNDROS, administer the first dose on an empty stomach at least 30 minutes before eating. Subsequent doses can be taken without regard to meals.

Because food can substantially change the systemic exposure to dronabinol and its active metabolite, the timing of dosing in relation to meal times should be kept consistent for each chemotherapy cycle, once the dosage has been determined from the titration process.

Dosage Titration

  • The dosage can be titrated to clinical response during a chemotherapy cycle or subsequent cycles, based upon initial effect, as tolerated to achieve a clinical effect, in increments of 2.1 mg/m2.
  • Maximum Dosage: 12.6 mg/m2 per dose for 4 to 6 doses per day.
  • Adverse reactions are dose-related and psychiatric symptoms increase significantly at the maximum dosage [see Warnings and Precautions (5.1)].

Monitor patients for adverse reactions and consider decreasing the dose to 2.1 mg once daily 1 to 3 hours prior to chemotherapy to reduce the risk of CNS adverse reactions.

3 DOSAGE FORMS AND STRENGTHS

Oral Solution: 5 mg/mL, a clear, pale yellow to brown solution.

4 CONTRAINDICATIONS

SYNDROS is contraindicated in patients:

  • with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions (6.2)].
  • with a history of a hypersensitivity reaction to alcohol.
  • who are receiving, or have recently received, disulfiram- or metronidazole-containing products within 14 days [see Warning and Precautions (5.3)]. SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol.

5 WARNINGS AND PRECAUTIONS

5.1 Neuropsychiatric Adverse Reactions

Psychiatric Adverse Reactions

Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Prior to initiating treatment with SYNDROS, screen patients for a history of these illnesses. Avoid use in patients with a psychiatric history or, if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Also, avoid concomitant use with other drugs that are associated with similar psychiatric effects.

Cognitive Adverse Reactions

Use of SYNDROS has been associated with cognitive impairment and altered mental state. Reduce the dose of SYNDROS or discontinue use of SYNDROS if signs or symptoms of cognitive impairment develop. Elderly and pediatric patients may be more sensitive to the neurological and psychoactive effects of SYNDROS [see Use in Specific Populations (8.4, 8.5)].

Hazardous Activities

SYNDROS can cause and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery. Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, and muscle relaxants). Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that SYNDROS does not affect them adversely.

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