Drizalma

Depression affects more than 6.5 million (20%) of the 35 million Americans aged 65 and older.²

~20%

1 million

Drizalma Sprinkle™ is indicated for
major depressive disorder in adults¹

Approximately 40% of American adults cannot or will not swallow solid forms of medication.³

0%

Swallow whole
Sprinkle over applesauce
Administer via nasogastric tube

INDICATIONS AND USAGE

Drizalma Sprinkle^TM (duloxetine) delayed-release capsules are indicated for the treatment of:

Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years
Diabetic Peripheral Neuropathic Pain (DPNP) in adults
Chronic musculoskeletal pain in adults

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

CONTRAINDICATIONS

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Drizalma Sprinkle^TM or within 5 days of stopping treatment with Drizalma Sprinkle^TM. Do not use Drizalma Sprinkle™ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Drizalma Sprinkle^TM in a patient who is being treated with linezolid or intravenous methylene blue.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Treatment should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Drizalma Sprinkle^TM should not be prescribed for patients with substantial alcohol use or evidence of chronic liver disease
Orthostatic Hypotension, Falls, and Syncope: Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during treatment, particularly after dose increases
Serotonin Syndrome: There is increased risk when coadministered with other serotonergic agents (eg, SSRIs, SNRIs, triptans), but also when taken alone. Monitor all patients taking Drizalma Sprinkle™ for the emergence of serotonin syndrome. If it occurs, discontinue Drizalma Sprinkle^TM and initiate supportive treatment
Increased Risk of Bleeding: Duloxetine may increase the risk of bleeding events. A post-marketing study showed a higher incidence of postpartum hemorrhage in mothers taking duloxetine. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk
Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome, can occur with duloxetine. Drizalma Sprinkle^TM should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified
Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible
Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with duloxetine or another antidepressant may precipitate a mixed/manic episode. Use cautiously in patients with bipolar disorder. Prior to initiating treatment with Drizalma Sprinkle^TM, screen patients for any personal or family history of bipolar disorder, mania, or hypomania
Angle-Closure Glaucoma: Duloxetine may trigger an angle-closure attack in patients with anatomically narrow angles who do not have a patent iridectomy. Avoid use of Drizalma Sprinkle™ in patients with anatomically narrow angles
Seizures: Drizalma Sprinkle^TM should be prescribed with care in patients with a history of seizure disorder
Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment
Hyponatremia: Can occur in association with SIADH. Cases of hyponatremia have been reported
Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose and HbA_1c have been observed

ADVERSE REACTIONS

The most common adverse reactions (≥5% and at least twice the incidence of placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

DOSING AND ADMINISTRATION

Drizalma Sprinkle^TM may be taken with or without food. Drizalma Sprinkle^TM may be swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube.

DRUG INTERACTIONS

Avoid concomitant use with potent CYP1A2 inhibitors
Consider dose reduction with concomitant use with CYP2D6 substrates

USE IN SPECIFIC POPULATIONS

Hepatic Impairment: Avoid use in patients with mild, moderate, or severe hepatic impairment
Renal Impairment: Avoid use in patients with severe renal impairment
Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Drizalma Sprinkle^TM. Third trimester use may increase risk of symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate. Advise patients that Drizalma Sprinkle^TM use during the month before delivery may lead to an increased risk for postpartum hemorrhage and may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support and tube feeding
Lactation: Advise breastfeeding women using duloxetine to monitor infants for sedation, poor feeding and poor weight gain and to seek medical care if they notice these signs

Alternative Formulation

Drizalma Sprinkle^TM

Designed for Long-Term Care (LTC) Residents Who Cannot or Will Not Swallow Solid Medication Forms¹

Depression affects more than 6.5 million (20%) of the 35 million Americans aged 65 and older.²

Approximately 40% of American adults cannot or will not swallow solid forms of medication.³

0%

In adults aged 65 and older, 7% met the criteria for an anxiety disorder over the past year.⁴

Drizalma Sprinkle^TM is indicated for generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years.¹

With 3 administration options designed to meet the needs of LTC residents, Drizalma Sprinkle^TM provides once-daily dosing that can be administered with or without meals.¹

3 administration options¹:

Alternative Formulation

Drizalma SprinkleTM

Designed for Long-Term Care (LTC) Residents Who Cannot or Will Not Swallow Solid Medication Forms¹

Depression affects more than 6.5 million (20%) of the 35 million Americans aged 65 and older.2

Approximately 40% of American adults cannot or will not swallow solid forms of medication.3

0%

In adults aged 65 and older, 7% met the criteria for an anxiety disorder over the past year.4

Drizalma SprinkleTM is indicated for generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years.1

With 3 administration options designed to meet the needs of LTC residents, Drizalma SprinkleTM provides once-daily dosing that can be administered with or without meals.1

3 administration options1:

No need for crushing; just open, sprinkle, and serve

Drizalma Sprinkle^TM

Depression affects more than 6.5 million (20%) of the 35 million Americans aged 65 and older.²

Approximately 40% of American adults cannot or will not swallow solid forms of medication.³

In adults aged 65 and older, 7% met the criteria for an anxiety disorder over the past year.⁴

Drizalma Sprinkle^TM is indicated for generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years.¹

With 3 administration options designed to meet the needs of LTC residents, Drizalma Sprinkle^TM provides once-daily dosing that can be administered with or without meals.¹

3 administration options¹: