Horizant

Horizant Manufacturers

• Glaxosmithkline Llc
  

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  Horizant | Glaxosmithkline Llc

  

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  Tablets should be swallowed whole and should not be cut, crushed, or chewed.

  Tablets should be taken with food.

  HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles [see Warnings and Precautions (5.3)].

  2.1 Restless Legs Syndrome

  The recommended dosage for HORIZANT is 600 mg once daily at about 5 PM. A daily dose of 1,200 mg provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions [see Adverse Reactions (6.1)].

  If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed.

  2.2 Postherpetic Neuralgia

  The recommended dosage of HORIZANT is 600 mg twice daily. HORIZANT should be initiated at a dose of 600 mg in the morning for 3 days of therapy, then increased to 600 mg twice daily (1,200 mg/day) on day four. In the 12-week principal efficacy study, additional benefit of using doses greater than 1,200 mg a day was not demonstrated, and these higher doses resulted in an increase in adverse reactions [see Adverse Reactions (6.1)].

  If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of the next scheduled dose.

  2.3 Renal Impairment

  Dosing of HORIZANT is adjusted in accordance with renal function, as represented by creatinine clearance [see Clinical Pharmacology (12.3)]. Target dose regimens are listed in Table 1 and Table 2.

  Table 1. Dosage of HORIZANT for Patients With Restless Legs Syndrome in Accordance With Creatinine Clearance

  Creatinine Clearance (mL/min)

  Target Dose Regimen

  ≥60

  600 mg per day

  30 - 59

  Start at 300 mg per day and increase to 600 mg as needed

  15 - 29

  300 mg per day

  <15

  300 mg every other day

  <15 on hemodialysis

  Not recommended

  Table 2. Dosage of HORIZANT for Patients With Postherpetic Neuralgia in Accordance With Creatinine Clearance

  Creatinine Clearance (mL/min)

  Titration

  Maintenance

  Tapering

  ≥60

  600 mg in AM for 3 days

  600 mg twice daily

  600 mg in AM for

  1 week

  30 - 59

  300 mg in AM for 3 days

  300 mg twice daily. Increase to 600 mg twice daily as neededa

  Reduce current maintenance dose to once daily in AM for 1 week

  15 - 29

  300 mg in AM on Day 1 and Day 3

  300 mg in AM. Increase to 300 mg twice daily if neededa

  If taking 300 mg twice daily, reduce to 300 mg once daily in AM for 1 week.

  If taking 300 mg once daily, no taper needed.

  <15

  None

  300 mg every other day in AM. Increase to 300 mg once daily in AM if neededa

  None

  <15 on hemodialysis

  None

  300 mg following every dialysis. Increase to 600 mg following every dialysis if neededa

  None

  aBased on tolerability and efficacy

  In patients with stable renal function, CrCl can be estimated using the equation of Cockcroft and Gault:

  for males: CrCl = (140-age)(weight)/[(72)(SCr)]

  for females: CrCl = (0.85)(140-age)(weight)/[(72)(SCr)]

  where age is in years, weight is in kilograms, and SCr is serum creatinine in mg/dL.

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• Xenoport Inc.
  

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  Horizant | Sanofi-aventis U.s. Llc

  

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  2.1 Route of Administration

  AFREZZA should only be administered via oral inhalation using the AFREZZA Inhaler. AFREZZA is administered using a single inhalation per cartridge.

  2.2 Dosage Information

  Administer AFREZZA at the beginning of the meal.

  Dosage adjustment may be needed when switching from another insulin to AFREZZA [see Warnings and Precautions (5.2)].

  Starting Mealtime Dose:

  Insulin Naïve Individuals: Start on 4 units of AFREZZA at each meal. Individuals Using Subcutaneous Mealtime (Prandial) Insulin: Determine the appropriate AFREZZA dose for each meal by converting from the injected dose using Figure 1. Individuals Using Subcutaneous Pre-mixed Insulin: Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1. Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.

  Figure 1. Mealtime AFREZZA Dose Conversion Table

  Mealtime Dose Adjustment

  Adjust the dosage of AFREZZA based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.

  Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.3), and Use in Specific Populations (8.6,8.7)].

  Carefully monitor blood glucose control in patients requiring high doses of AFREZZA. If, in these patients, blood glucose control is not achieved with increased AFREZZA doses, consider use of subcutaneous mealtime insulin.

  2.3 AFREZZA Administration for Doses Exceeding 12 units

  For AFREZZA doses exceeding 12 units, inhalations from multiple cartridges are necessary. To achieve the required total mealtime dose, patients should use a combination of 4 unit, 8 unit and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, combinations of different multiple cartridges can be used.

  2.4 Dosage Adjustment due to Drug Interactions

  Dosage adjustment may be needed when AFREZZA is coadministered with certain drugs [see Drug Interactions (7)].

  2.5 Lung Function Assessment Prior to Administration

  AFREZZA is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients. Before initiating AFREZZA, perform a medical history, physical examination and spirometry (FEV1) in all patients to identify potential lung disease [see Contraindications (4) and Warnings and Precautions (5.1)].

  2.6 Important Administration Instructions

  See Patient Instructions for Use for complete administration instructions with illustrations.

  Keep the inhaler level with the white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler. Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, shaken (or dropped) after the cartridge has been inserted but before the dose has been administered. If any of the above occur, the cartridge should be replaced before use.

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