Sprinkledosage

Take DRIZALMA SPRINKLE with or without food

DRIZALMA SPRINKLE may be: swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube

Take a missed dose as soon as it is remembered. Do not take two doses of DRIZALMA SPRINKLE at the same time Indication Starting Dose Target Dose Maximum Dose MDD Adults 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP 60 mg/day 60 mg/day (once daily) 60 mg/day FM Adults 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain Adults 30 mg/day 60 mg/day (once daily) 60 mg/day

There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent

Discontinuing DRIZALMA SPRINKLE: Gradually reduce dosage to avoid discontinuation symptoms

2.1 Important

Administration Instructions Administer DRIZALMA SPRINKLE with or without food. Swallow DRIZALMA SPRINKLE whole (do not chew or crush the capsule). For patients unable to swallow an intact capsule, refer to the alternative administration instructions below. Directions for use with applesauce For patients with swallowing difficulty, DRIZALMA SPRINKLE can be opened and the contents sprinkled over applesauce. The contents of the capsules should be swallowed along with a small amount (tablespoonful) of applesauce. The drug/food mixture should be swallowed immediately and not stored for future use. Nasogastric tube administration Open and add contents of capsule to an all plastic catheter tip syringe and add 50 mL of water. Gently shake the syringe for approximately 10 seconds. Promptly deliver through a 12 French or larger nasogastric tube. Ensure no pellets are left in the syringe. Rinse with additional water (about 15 mL) if needed. If a dose of DRIZALMA SPRINKLE is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of DRIZALMA SPRINKLE at the same time.

2.2 Dosage for

Treatment of Major Depressive Disorder in Adults The recommended starting dosage in adults with MDD is 40 mg per day (given as 20 mg twice daily) to 60 mg per day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to DRIZALMA SPRINKLE before increasing to 60 mg once daily. While a 120 mg per day dose was shown to be effective, there is no evidence that doses greater than 60 mg per day confer any additional benefits. Periodically reassess to determine the need for maintenance treatment and the appropriate dosage for such treatment.

2.3 Dosage for

Treatment of Generalized Anxiety Disorder Recommended Dosage in Adults Less than 65 Years of Age For most adults less than 65 years of age with GAD, initiate DRIZALMA SPRINKLE 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to DRIZALMA SPRINKLE before increasing to 60 mg once daily. While a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg per day confer additional benefit. Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dosage for such treatment. Recommended Dosage in Geriatric Patients In geriatric patients with GAD, initiate DRIZALMA SPRINKLE at a dosage of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg per day. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Recommended Dosage in Pediatric Patients 7 to 17 Years of Age Initiate DRIZALMA SPRINKLE in pediatric patients 7 to 17 years of age with GAD at a dosage of 30 mg once daily for 2 weeks before considering an increase to 60 mg once daily. The recommended dosage range is 30 to 60 mg once daily. Some patients may benefit from dosages above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. The maximum dose studied was 120 mg per day.

2.4 Dosage for

Treatment of Diabetic Peripheral Neuropathic Pain in Adults Administer DRIZALMA SPRINKLE 60 mg once daily in adults with diabetic peripheral neuropathic pain. There is no evidence that doses higher than 60 mg once daily confer additional significant benefit and the higher dosage is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, consider a lower starting dosage and gradual increase in dosage for patients with renal impairment.

2.5 Dosage for

Treatment of Fibromyalgia in Adults Recommended Dosage in Adults The recommended DRIZALMA SPRINKLE dosage is 60 mg once daily in adults with fibromyalgia. Begin treatment at 30 mg once daily for 1 week, to allow patients to adjust to DRIZALMA SPRINKLE before increasing to 60 mg once daily. Some patients may respond to the starting dosage. There is no evidence that dosages greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg/day dosage, and higher dosages were associated with a higher rate of adverse reactions. Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.6 Dosage for

Treatment of Chronic Musculoskeletal Pain in Adults The recommended DRIZALMA SPRINKLE dosage is 60 mg once daily in adults with chronic musculoskeletal pain. Begin treatment at 30 mg once daily for one week, to allow patients to adjust to DRIZALMA SPRINKLE before increasing to 60 mg once daily. There is no evidence that higher dosage confer additional benefit, even in patients who do not respond to a 60 mg once daily dosage, and higher dosages are associated with a higher rate of adverse reactions.

2.7 Dosage Recommendations for

Concomitant Use with Potent CYP1A2 Inhibitors Coadministration with potent CYP1A2 Inhibitors: Avoid concomitant use of DRIZALMA SPRINKLE with potent CYP1A2 inhibitors.

2.8 Dosage in

Patients with Hepatic Impairment or Severe Renal Impairment Avoid use in patients with chronic liver disease or cirrhosis. Avoid use in patients with severe renal impairment, GFR <30 mL/minute.

2.9 Screen for

Bipolar Disorder Prior to Starting DRIZALMA SPRINKLE Prior to initiating treatment with DRIZALMA SPRINKLE or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.10 Discontinuing DRIZALMA SPRINKLE

Adverse reactions may occur upon discontinuation of DRIZALMA SPRINKLE. Gradually reduce the dosage rather than stopping DRIZALMA SPRINKLE abruptly whenever possible.

2.11 Switching a

Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with DRIZALMA SPRINKLE. Conversely, at least 5 days should be allowed after stopping DRIZALMA SPRINKLE before starting an MAOI intended to treat psychiatric disorders. In some cases, a patient already receiving DRIZALMA SPRINKLE therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, DRIZALMA SPRINKLE should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with DRIZALMA SPRINKLE may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with DRIZALMA SPRINKLE is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.