• Treatment of Malignant Hyperthermia (MH) (2.1)
  • Administer by intravenous push at a minimum of 1 mg/kg. If signs continue, administer additional intravenous boluses up to maximum cumulative dosage of 10 mg/kg.
  • Institute supportive measures (e.g., discontinue MH-triggering agents, manage metabolic acidosis, cooling if necessary, administer diuretics)
• Prevention of MH in Patients at High Risk (2.2)
  • Administer 2.5 mg/kg intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery.
  • Avoid agents that trigger MH.
  • Administer additional individualized doses during anesthesia and surgery if surgery is prolonged.
• Pediatric Patients: recommended weight-based dose is the same as for adults (2.3)
• Reconstitution: With 5 mL of sterile water for injection (without a bacteriostatic agent) prior to administration (2.4)

For injectable suspension: 250 mg of lyophilized powder in a single-use vial for reconstitution (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

• Skeletal muscle weakness: Ambulate patients with assistance until they have normal strength and balance (5.1)
• Dyspnea, respiratory muscle weakness, and decreased inspiratory capacity: Monitor patients for the adequacy of ventilation (5.1)
• Dysphasia: Assess patients for difficulty swallowing and choking (5.1)
• Somnolence and dizziness: Can occur following RYANODEX administration; may persist up to 48-hours post-dose. Ambulate patients with assistance until they have normal strength and balance.(5.2)
• Tissue Necrosis with extravasation: Due to high pH of reconstituted RYANODEX for injectable suspension, care must be taken to prevent extravasation into surrounding tissues (5.3)

• Administration to conscious subjects is associated with loss of grip strength and weakness in the legs, drowsiness and dizziness.
• Other common adverse reactions are: nausea, thrombophlebitis, tissue necrosis secondary to extravasation, urticaria and erythema, and injection site reactions (pain, erythema, swelling) (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eagle at
1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Calcium channel blockers: Concomitant use can cause cardiovascular collapse in association with marked hyperkalemia (7.1)
• Muscle relaxants: Concomitant use with muscle relaxants may potentiate their effects (7.2)
• Sedatives: Concomitant use with sedative agents may potentiate their effects (7.3)

• Pregnancy: Based on animal data, may cause fetal harm (8.1)
• Nursing Mothers: Discontinue drug or nursing (8.3)