Vertex Pharmaceuticals Incorporated

Vertex Pharmaceuticals Incorporated Drugs

• Orkambi
  

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  Orkambi

  

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  2.1 Dosing Information in Adults and Children Age 12 Years and Older

  Adults and pediatric patients age 12 years and older: two tablets (each containing lumacaftor 200 mg/ivacaftor 125 mg) taken orally every 12 hours with fat-containing food. Examples of appropriate fat-containing foods include eggs, avocados, nuts, butter, peanut butter, cheese pizza, whole-milk dairy products (such as whole milk, cheese, and yogurt), etc. If a patient misses a dose and remembers the missed dose within 6 hours, the patient should take the dose with fat-containing food. If more than 6 hours elapsed after the usual dosing time, the patient should skip that dose and resume the normal schedule for the following dose. A double dose should not be taken to make up for the forgotten dose [see Clinical Pharmacology (12.3) and Patient Counseling Information (17)].

  2.2 Dosage Adjustment for Patients with Hepatic Impairment

  No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A). A dose reduction to 2 tablets in the morning and 1 tablet in the evening (lumacaftor 600 mg/ivacaftor 375 mg total daily dose) is recommended for patients with moderate hepatic impairment (Child-Pugh Class B).

  Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C), but exposure is expected to be higher than in patients with moderate hepatic impairment. Therefore, use with caution at a maximum dose of 1 tablet in the morning and 1 tablet in the evening (lumacaftor 400 mg/ivacaftor 250 mg total daily dose), or less, in patients with severe hepatic impairment after weighing the risks and benefits of treatment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

  2.3 Dosage Adjustment for Patients Taking CYP3A Inhibitors

  No dose adjustment is necessary when CYP3A inhibitors are initiated in patients already taking ORKAMBI. However, when initiating ORKAMBI in patients currently taking strong CYP3A inhibitors (e.g., itraconazole), reduce ORKAMBI dose to 1 tablet daily (lumacaftor 200 mg/ivacaftor 125 mg total daily dose) for the first week of treatment. Following this period, continue with the recommended daily dose.

  If ORKAMBI is interrupted for more than 1 week and then re-initiated while taking strong CYP3A inhibitors, patients should reduce ORKAMBI dose to 1 tablet daily for the first week of treatment re-initiation. Following this period, continue with the recommended daily dose.

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• Incivek
  

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  Incivek

  

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  2.1 INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment

  The recommended dose of INCIVEK tablets is 1125 mg (three 375-mg tablets) taken orally twice daily (10-14 hours apart) with food (not low fat) [see Clinical Pharmacology (12.3)].

  For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information.

  Duration of Treatment

  The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).

  Table 1: Recommended Treatment Duration (See also Table 2 for Treatment Futility Rules) * In clinical trials, HCV RNA in plasma was measured using a COBAS ® TaqMan ® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. See Laboratory Tests (5.5) for a description of HCV RNA assay recommendations. Treatment-Naïve and Prior Relapse Patients Triple Therapy Dual Therapy Total Treatment Duration HCV RNA* INCIVEK,peginterferon alfa and ribavirin peginterferon alfa and ribavirin Undetectable (Target Not Detected) at Weeks 4 and 12 First 12 weeks Additional 12 weeks 24 weeks Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks Prior Partial and Null Responder Patients Triple Therapy Dual Therapy Total Treatment Duration INCIVEK, peginterferon alfa and ribavirin peginterferon alfa and ribavirin All Patients First 12 weeks Additional 36 weeks 48 weeks

  For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an "undetectable" HCV RNA (Target Not Detected) result is required; a confirmed "detectable but below limit of quantification" HCV RNA result should not be considered equivalent to an "undetectable" HCV RNA (Target Not Detected) result [see Laboratory Tests (5.5)].

  Treatment-naïve patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies (14.2)].

  2.2 Dose Reduction

  To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see Warnings and Precautions (5.6)].

  2.3 Discontinuation of Dosing

  Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology (12.4)]. Discontinuation of therapy is recommended in all patients with (1) HCV RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV RNA levels at Treatment Week 24 (see Table 2).

  Table 2: Treatment Futility Rules: All Patients HCV RNA Action Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks) Week 24: Detectable Discontinue peginterferon alfa and ribavirin

  If peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.

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• Kalydeco
  

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  Kalydeco

  

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  2.1 General Dosing Information

  KALYDECO should be taken with fat-containing food. Examples include eggs, butter, peanut butter, cheese pizza, whole-milk dairy products (such as whole milk, cheese, and yogurt), etc. [see Clinical Pharmacology (12.3) and Patient Counseling Information (17)].

  2.2 Dosing Information in Adults and Children Ages 6 Years and Older

  The recommended dose of KALYDECO for both adults and pediatric patients age 6 years and older is one 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food [see Dosage and Administration (2.1)].

  2.3 Dosing Information in Pediatric Patients Ages 2 to less than 6 Years

  The recommended dose of KALYDECO (oral granules) for patients ages 2 to less than 6 years is weight-based according to Table 1.

  Table 1: Dosage of KALYDECO Oral Granules by Body Weight in Pediatric Patients Ages 2 to less than 6 Years Body Weight (kg) KALYDECO Dose Total Daily Dose Less than 14 kg One 50 mg packet every 12 hours 100 mg/day 14 kg or greater One 75 mg packet every 12 hours 150 mg/day

  The entire contents of each packet of oral granules should be mixed with one teaspoon (5 mL) of age-appropriate soft food or liquid and completely consumed. Food or liquid should be at or below room temperature. Once mixed, the product has been shown to be stable for one hour, and therefore should be consumed during this period. Some examples of soft foods or liquids may include puréed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Each dose should be administered just before or just after fat-containing food [see Dosage and Administration (2.1)].

  2.4 Dosing Information in Pediatric Patients less than 2 Years

  A safe and efficacious dose of KALYDECO for pediatric patients less than 2 years of age has not been established. The use of KALYDECO (oral granules) in children under the age of 2 years is not recommended.

  2.5 Dosage Adjustment for Patients with Hepatic Impairment

  The dose of KALYDECO should be reduced to one tablet or one packet of oral granules once daily for patients with moderate hepatic impairment (Child-Pugh Class B). KALYDECO should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) at a dose of one tablet or one packet of oral granules once daily or less frequently [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

  2.6 Dosage Adjustment for Patients Taking Drugs that are CYP3A Inhibitors

  When KALYDECO is being co-administered with strong CYP3A inhibitors (e.g., ketoconazole), the dose should be reduced to one tablet or one packet of oral granules twice a week. The dose of KALYDECO should be reduced to one tablet or one packet of granules once daily when co-administered with moderate CYP3A inhibitors (e.g., fluconazole). Food containing grapefruit or Seville oranges should be avoided [see Drug Interactions (7.1), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

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