Voydeya

• Complete or update vaccination for encapsulated bacteria specifically,

  Neisseria meningitidis

  and

  Streptococcus pneumoniae

  at least 2 weeks prior to the first dose of VOYDEYA, unless the risks of delaying therapy with VOYDEYA outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. See

  5.1 Serious Infections Caused by Encapsulated Bacteria

  VOYDEYA, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including

  Neisseria meningitidis

  (caused by any serogroup, including non-groupable strains),

  Streptococcus pneumoniae

  , and

  Haemophilus influenzae

  type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of VOYDEYA treatment is contraindicated in patients with unresolved serious infections caused by encapsulated bacteria.

  Complete or update vaccination against encapsulated bacteria, specifically

  Neisseria meningitidis

  and

  Streptococcus pneumoniae

  at least 2 weeks prior to administration of the first dose of VOYDEYA, according to the current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with VOYDEYA. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent VOYDEYA therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including VOYDEYA. The benefits and risks of treatment with VOYDEYA, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.

  Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of VOYDEYA in patients who are undergoing treatment for serious infections.

  VOYDEYA is available only through a restricted program under a REMS

  [see Warnings and Precautions (5.2)]

  .

  for additional guidance on the management of the risk of serious infections caused by encapsulated bacteria.
• Patients receiving VOYDEYA are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.

VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).

• Start 150 mg three times a day orally, with or without food. Depending on clinical response, can increase to 200 mg three times a day.
• See Full Prescribing Information for instructions on dosage and administration (
  2.1 Recommended Vaccination and Prophylaxis for Encapsulated Bacterial Infections

  Vaccinate patients against encapsulated bacteria, including

  Neisseria meningitidis

  (serogroups A, C, W, Y, and B) and

  Streptococcus pneumoniae

  according to current ACIP recommendations at least 2 weeks prior to initiation of VOYDEYA.

  If urgent VOYDEYA therapy is indicated in a patient who is not up to date with vaccines for

  Neisseria meningitidis

  and

  Streptococcus pneumoniae

  according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible

  [see Warnings and Precautions (5.1)]

  .

  Healthcare professionals who prescribe VOYDEYA must enroll in the VOYDEYA REMS

  [see Warnings and Precautions (5.2)]

  .
  ,
  2.2 Recommended Dosage

  Starting Dose:

  The recommended dosage of VOYDEYA is 150 mg three times a day administered orally.

  VOYDEYA can be taken with or without food.

  Dose Adjustment:

  The dose can be increased to 200 mg three times a day if the patient's hemoglobin (Hgb) level has not increased by greater than 2 g/dL after 4 weeks of therapy, if the patient required a transfusion during the previous 4 weeks, or to achieve an appropriate Hgb response based on clinical judgement.

  Missed Doses

  A patient who misses a dose of VOYDEYA should take it as soon as they remember unless it is within 3 hours prior to their next dose, in which case the patient should skip the missed dose and take VOYDEYA at the next regularly scheduled time. Patients should not take two or more doses of VOYDEYA at the same time.
  ).

Tablets: 50 mg and 100 mg (

Hepatic Impairment: Avoid use in patients with severe hepatic impairment (Child-Pugh C) (