Pegintron and Rebetol
"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
PegIntron and Rebetol Combo Pack
DOSAGE AND ADMINISTRATION
There are no safety and efficacy data on treatment for longer than one year. A patient should self-inject Peglntron™ only if it has been determined that it is appropriate and the patient agrees to medical follow-up as necessary and training in proper injection technique has been given to him/her.
Treatment discontinuation is also recommended for patients who do not achieve an undetectable HCV RNA viral load at 24 weeks of therapy of therapy. The recommended dose of Peglntron™ is 1.5 mcg/kg/week in combination with 8001400 mg REBETOL® based on patient body weight. The volume of Peglntron™ to be injected depends on the strength of Peglntron™ and patient's body weight. (See Table 5.)
The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.
TABLE 5: Recommended Peglntron™/REBETOL® Combo Pack
|Body weight kg (lbs)||Peglntron™ REDIPEN® Strength to Use||Amount of Peglntron™ (meg) to Administer||Volume (mL)* of Peglntron™ to Administer||REBETOL® Daily Dose||REBETOL® Number of Capsules|
|< 40 ( < 87)||50 meg per 0.5 mL||50||0.5||800 mg/day||2x200 mgcapsules A.M.
2x200 mgcapsules P.M.
|40-50 (87-111)||80 meg per 0.5 mL||64||0.4||800 mg/day||2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
|51-60 (112-133)||80||0.5||800 mg/day||2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
|61-65 (134-144)||120 meg per 0.5 mL||96||0.4||800 mg/day||2 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
|66-75 (145-166)||96||0.4||1000 mg/day||2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
|76-85 (167-188)||120||0.5||1000 mg/day||2 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
|86-105 (189-231)||150 meg per 0.5 mL||150||0.5||1200 mg/day||3 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
|> 105 ( > 231)||1400 mg/day||3 x 200 mg capsules A.M.
4 x 200 mg capsules P.M.
|* When reconstituted as directed.|
REBETOL® should be taken with food. Peglntron™/REBETOL® Combo Pack therapy should not be used in patients with creatinine clearance < 50 mL/min.
If a serious adverse reaction develops during the course of treatment (See WARNINGS) discontinue or modify the dosage of Peglntron™ and/or REBETOL® until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. For guidelines for dose modifications and discontinuation based on laboratory parameters, see Tables 6 and 7. Dose reduction of Peglntron™ may be accomplished by utilizing a lower dose strength as shown in Table 8.
Peglntron™/REBETOL® Combo Pack therapy should not be used in patients with creatinine clearance < 50 mL/min. (See PRECAUTIONS and CLINICAL PHARMACOLOGY, Special populations.) Subjects with impaired renal function and/or those over the age of 50 should be more carefully monitored with respect to development of anemia.
In the combination therapy trial, dose reductions occurred among 42% of patients receiving Peglntron™ 1.5 mcg/kg/REBETOL® 800 mg daily including 57% of those patients weighing 60 kg or less (see ADVERSE REACTIONS).
Table 6: Guidelines for Modification or
Discontinuation of Peglntron™/REBETOL® Combo Pack Therapy and for
Scheduling Visits for Patients with Depression
|Depression Severity1||Initial Management (4-8 wks)||Depression|
|Dose modification||Visit schedule||Remains stable||Improves||Worsens|
|Mild||No change||Evaluate once weekly by visit and/or phone.||Continue weekly visit schedule.||Resume normal visit schedule.||(See moderate or severe depression)|
|Moderate||Decrease IFN dose 50%||Evaluate once weekly (office visit at least every other week).||Consider psychiatric consultation. Continue reduced dosing.||If symptoms improve and are stable for 4 wks, may resume normal visit schedule. Continue reduced dosing or return to normal dose.||(See severe depression)|
|Severe||Discontinue IFN/R permanently.||Obtain immediate psychiatric consultation.||Psychiatric therapy as necessary|
|1 See DSM-IV for definitions.|
Table 7: Guidelines for Dose Modification and
Discontinuation of Peglntron™/REBETOL® Combo Pack Therapy for
|Hgb*||< 10 g/dL||-----------||Decrease by 200 mg/day|
|< 8.5 g/dL||Permanently discontinue||Permanently discontinue|
|WBC||< 1.5 x 109/L||Reduce dose by 50%||-----------|
|< 1 x 109/L||Permanently discontinue||Permanently discontinue|
|Neutrophil||< 0.75 x 109/L||Reduce dose by 50%||-----------|
|< 0.5 x109/L||Permanently discontinue||Permanently discontinue|
|Platelets||< 80 x 109/L||Reduce dose by 50%||-----------|
|< 50 x 109/L||Permanently discontinue||Permanently discontinue|
|* For patients with a history of stable cardiac disease receiving Peglntron™ in combination with ribavirin, the Peglntron™ dose should be reduced by half and the ribavirin dose by 200 mg/day if a > 2 g/dL decrease in hemoglobin is observed during any 4-week period. Both Peglntron™ and ribavirin should be permanently discontinued if patients have hemoglobin levels < 12 g/dL after this ribavirin dose reduction.|
TABLE 8: Reduced Peglntron™ Dose (0.75 mcg/kg) for
(1.5 mcg/kg) Combination Therapy
|Body weight kg (lbs)||Peglntron™ REDIPEN® Strength to Use||Amount of Peglntron™ (meg) to Administer||Volume (mL)** of Peglntron™ to Administer|
|< 40 ( < 87)||50 meg per 0.5 mL*||25||0.25|
|40-50 ( < 87-111)||50 meg per 0.5 mL||30||0.3|
|61-75 (134-166)||50 meg per 0.5 mL||50||0.5|
|76-85 (167-188)||80 meg per 0.5 mL||64||0.4|
|> 85 ( > 188)||80||0.5|
|* Must use vial. Minimum delivery for REDIPEN® 0.3 Ml
** When reconstituted as directed
Preparation and Administration
Peglntron™ REDIPEN® consists of a dual-chamber glass cartridge with sterile, lyophilized peginterferon alfa-2b in the active chamber and Sterile Water for Injection, USP in the diluent chamber. The Peglntron™ in the glass cartridge should appear as a white to off-white tablet-shaped solid that is whole or in pieces, or powder. To reconstitute the lyophilized peginterferon alfa-2b in the REDIPEN®, hold the REDIPEN® upright (dose button down) and press the two halves of the pen together until there is an audible click. Gently invert the pen to mix the solution. DO NOT SHAKE. The reconstituted solution has a concentration of either 50 meg per 0.5 mL, 80 meg per 0.5 mL, 120 meg per 0.5 mL, or 150 meg per 0.5 mL for a single subcutaneous injection. Visually inspect the solution for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless. Do not use the solution if it is discolored or not clear, or if particulates are present.
Keeping the pen upright, attach the supplied needle and select the appropriate Peglntron™ dose by pulling back on the dosing button until the dark bands are visible and turning the button until the dark band is aligned with the correct dose. The prepared Peglntron™ solution is to be injected subcutaneously.
The Peglntron™ REDIPEN® is a single-use pen and does not contain a preservative. The reconstituted solution should be used immediately and cannot be stored for more than 24 hours at 2°-8°C (See Storage). DO NOT REUSE THE REDIPEN®. The sterility of any remaining product can no longer be guaranteed. DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.
After preparation and administration of the Peglntron™ REDIPEN®, it is essential to follow the state and/or local procedures for proper disposal of the REDIPEN®. A puncture-resistant container should be used for disposal. Patients should be instructed in how to properly dispose of used REDIPEN® and be cautioned against the reuse of these items.
Peglntron™/REBETOL® Combo Pack package should be stored at 2°- 8°C (36°-46°F).
When separated, the individual bottle of REBETOL® Capsules should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
When separated, the Peglntron™ REDIPEN® should be stored at 2°- 8°C (36°- 46°F). After reconstitution, the solution should be used immediately, but may be stored up to 24 hours at 2°-8°C (36°-46°F). The reconstituted solution contains no preservative, and is clear and colorless. DO NOT FREEZE.
Peglntron™ REDIPEN® is a dual-chamber glass cartridge containing lyophilized Peglntron™ as a white to off-white tablet or powder that is whole or in pieces in the sterile active chamber and a second chamber containing Sterile Water for Injection, USP.
REBETOL® 200 mg Capsules are white, opaque capsules with REBETOL®, 200 mg, and the Schering Corporation logo imprinted on the capsule shell.
|Each Peglntron™/REBETOL® Combo Pack Consists of:|
|A box containing four 50 meg per 0.5 mL Peglntron™ REDIPEN® Units, each containing 1 BD® needle and 2 alcohol swabs, and two bottles of 56 REBETOL® Capsules.||(NDC 0085-1367-01)|
|A box containing four 80 meg per 0.5 mL Peglntron™ REDIPEN® Units, each containing 1 BD® needle and 2 alcohol swabs, and two bottles of 56 REBETOL® Capsules.||(NDC 0085-1375-01)|
|A box containing four 120 meg per 0.5 mL Peglntron™ REDIPEN® Units, each containing 1 BD® needle and 2 alcohol swabs, and two bottles of 70 REBETOL® Capsules.||(NDC 0085-1456-01)|
|A box containing four 150 meg per 0.5 mL Peglntron™ REDIPEN® Units, each containing 1 BD® needle and 2 alcohol swabs, and two bottles of 84 REBETOL® Capsules.||(NDC 0085-1555-01)|
|A box containing four 150 meg per 0.5 mL Peglntron™ REDIPEN® Units, each containing 1 BD® needle and 2 alcohol swabs, and two bottles of 98 REBETOL® Capsules.||(NDC 0085-1684-01)|
Schering Corporation, Kenilworth, NJ 07033 USA. Revision: 5/08This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2013
Additional PegIntron and Rebetol Combo Pack Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.