DESMOPRESSIN Drug Interactions: What You Need to Know

INTERACTIONS Drugs that increase risk of hyponatremia: Require more frequent serum sodium monitoring. ( 7.1 ) Other vasoconstrictors: May require a reduction of the Desmopressin Acetate dosage. ( 7.2 )

7.1 Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of Desmopressin Acetate Injection USP with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, sulfonylureas, particularly chlorpropamide, oxybutynin and carbamazepine), requires more frequent serum sodium monitoring. Monitor serum sodium more frequently in patients taking Desmopressin Acetate Injection USP concomitantly with these drugs and when doses of these drugs are increased <span class="opacity-50 text-xs">[see Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7.1) , Use in Specific Populations (8.4 , 8.5) ]</span> .

7.2 Other Vasoconstrictors Desmopressin Acetate Injection USP can elevate blood pressure. Use of Desmopressin Acetate Injection USP with other vasoconstrictors may require a reduction of the Desmopressin Acetate Injection USP dosage <span class="opacity-50 text-xs">[see Warnings and Precautions (5.2) , Adverse Reactions (6) ]</span>.

Desmopressin Acetate Injection USP is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection USP [see Warnings and Precautions (5.4) , Adverse Reactions (6) , Description (11) ] .

Desmopressin Acetate

Injection USP is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min [see Use in Specific Populations (8.5 , 8.6) and Clinical Pharmacology (12.3) ] . Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ], Use in Specific Populations (8.4 , 8.5) ] . Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (5.1 )] . Polydipsia [see Warnings and Precautions (5.1) ] . Concomitant use with loop diuretics [see Boxed Warning ] . Concomitant use with systemic or inhaled glucocorticoids [see Boxed Warning ] . During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see Boxed Warning ] .

Desmopressin Acetate

Injection USP is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: Heart failure Uncontrolled hypertension Known hypersensitivity to desmopressin acetate or to any of the components ( 4 ) Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min ( 4 ) Hyponatremia or a history of hyponatremia ( 4 ) Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion ( 4 ) Polydipsia ( 4 ) Concomitant use with loop diuretics or systemic or inhaled glucocorticoids ( 4 ) During illnesses that can cause fluid or electrolyte imbalance ( 4 ) Heart failure or uncontrolled hypertension ( 4 )

AND PRECAUTIONS Hypotension and Hypertension: May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during Desmopressin Acetate Injection administration, especially in patients with heart disease. ( 5.2 )

Increased

Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB: Use of Desmopressin Acetate Injection in patients with Type IIB von Willebrand’s disease may cause thrombosis due to platelet aggregation. ( 5.3 )

Hypersensitivity

Reactions: Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs. ( 5.4 )

Fluid

Retention: Fluid retention can worsen underlying conditions that are susceptible to volume status. Not recommended in patients at risk for increased intracranial pressure or with a history of urinary retention. ( 5.5 )

5.1 Hyponatremia Desmopressin Acetate Injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death <span class="opacity-50 text-xs">[see Boxed Warning ]</span>.

Desmopressin Acetate

Injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances [see Contraindications ( 4 ), Drug Interactions ( 7 )]. Avoid concomitant treatments that also cause hyponatremia. Prior to starting or resuming Desmopressin Acetate Injection, ensure that the serum sodium concentration is normal. Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration. Use of Desmopressin Acetate Injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia. Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating Desmopressin Acetate Injection, and periodically thereafter [see Dosage and Administration ( 2.1 )]. Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia. Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia [see Contraindications ( 4 )]. If hyponatremia occurs, Desmopressin Acetate Injection may need to be temporarily or permanently discontinued and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia.

5.2 Hypotension and Hypertension Desmopressin Acetate Injection may cause hypotension (with compensatory increase in heart rate) or hypertension. Monitor blood pressure during Desmopressin Acetate Injection administration, particularly in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease <span class="opacity-50 text-xs">[see Adverse Reactions ( 6 ), Drug Interactions ( 7.2 )]</span>

5.3 Increased Risk of Thrombosis in Patients with von Willebrand&apos;s Disease Type IIB Use of Desmopressin Acetate Injection in patients with Type IIB von Willebrand’s disease may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.

5.4 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal Desmopressin Acetate Injection, including cases of fatal anaphylaxis with intravenous Desmopressin Acetate Injection.

Desmopressin Acetate

Injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection [see Contraindications ( 4 )]. It is not known whether antibodies to Desmopressin Acetate Injection are produced after repeated injections. Monitor patients for signs or symptoms of hypersensitivity reactions during administration, interrupt treatment should a reaction occur, and manage medically. Permanently discontinue for serious hypersensitivity reaction [see Adverse Reactions ( 6 )].

5.5 Fluid Retention Desmopressin Acetate Injection can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. Patients with heart failure or uncontrolled hypertension may be at increased risk.

Desmopressin Acetate

Injection is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention.Advise patients to limit fluid intake [see Patient Counseling Information ( 17 )].