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Otrexup

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Otrexup

INDICATIONS

Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis

Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

Psoriasis

Otrexup is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.

Limitation of Use

Otrexup is not indicated for the treatment of neoplastic diseases.

DOSAGE AND ADMINISTRATION

Important Dosing Information

Otrexup is a single-dose auto-injector for once-weekly subcutaneous use only [see WARNINGS AND PRECAUTIONS]. Administer Otrexup in the abdomen or the thigh. Otrexup is only available in doses between 10 to 25 mg in 5 mg increments. Use another formulation of methotrexate for alternative dosing in patients who require oral, intramuscular, intravenous, intra-arterial, or intrathecal dosing, doses less than 10 mg per week, doses more than 25 mg per week, high-dose regimens, or dose adjustments of less than 5 mg increments.

Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis

Recommended starting dose of methotrexate:

Adult RA: single oral doses of 7.5 mg weekly using an oral formulation of methotrexate.

pJIA: 10 mg/m² once weekly.

For patients switching from oral methotrexate to Otrexup, consider any differences in bioavailability between oral and subcutaneously administered methotrexate [see CLINICAL PHARMACOLOGY].

Dosages may be adjusted gradually to achieve an optimal response. Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg/wk in adults. Although there is experience with doses up to 30 mg/m²/wk in children, there are too few published data to assess how doses over 20 mg/m²/wk might affect the risk of serious toxicity in children. Experience does suggest, however, that children receiving 20 to 30 mg/m²/wk (0.65 to 1.0 mg/kg/wk) may have better absorption and fewer gastrointestinal side effects if methotrexate is administered either intramuscularly or subcutaneously.

Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

The optimal duration of therapy is unknown. Limited data available from long-term studies in adults indicate that the initial clinical improvement is maintained for at least two years with continued therapy. When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks.

The patient should be fully informed of the risks involved and should be under constant supervision of the physician. Assessment of hematologic, hepatic, renal, and pulmonary function should be made by history, physical examination, and laboratory tests before beginning, periodically during, and before reinstituting Otrexup therapy [see WARNINGS AND PRECAUTIONS]. Females of childbearing potential should not be started on Otrexup until pregnancy is excluded [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

All schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects.

Maximal myelosuppression usually occurs in seven to ten days.

Psoriasis

Recommended starting dose of methotrexate:

Psoriasis: single weekly oral, intramuscular, subcutaneous, or intravenous doses of 10-25 mg.

For patients switching from oral methotrexate to Otrexup, consider any differences in bioavailability between oral and subcutaneously administered methotrexate [see CLINICAL PHARMACOLOGY].

Dosage may be gradually adjusted to achieve optimal clinical response; 30 mg/week should not ordinarily be exceeded. Once optimal clinical response has been achieved, the dosage should be reduced to the lowest possible amount of drug and to the longest possible rest period. The use of Otrexup may permit the return to conventional topical therapy, which should be encouraged.

Administration and Handling

Otrexup is an auto-injector intended for subcutaneous use under the guidance and supervision of a physician.

Patients may self-inject with Otrexup if a physician determines that it is appropriate, if they have received proper training in how to prepare and administer the correct dose, and if they receive medical follow-up, as necessary. A trainer device is available for training purposes.

Visually inspect Otrexup for particulate matter and discoloration prior to administration. Do not use Otrexup if the seal is broken.

Handle and dispose of Otrexup consistent with recommendations for handling and disposal of cytotoxic drugs1.

HOW SUPPLIED

Dosage Forms And Strengths

Otrexup is an injection available as an autoinjector that administers a single 0.4 mL dose of methotrexate solution in the following dosage strengths:

  • 10 mg/0.4 mL methotrexate
  • 15 mg/0.4 mL methotrexate
  • 20 mg/0.4 mL methotrexate
  • 25 mg/0.4 mL methotrexate

Storage And Handling

Otrexup contains methotrexate in a preservative-free sterile solution for a single subcutaneous injection. Otrexup is available in the following strengths and configurations.

Otrexup (methotrexate) injection 10 mg/0.4 mL

Carton of 1 NDC 54436-010-01
Carton of 4 NDC 54436-010-04
Otrexup NDC 54436-010-02

Otrexup (methotrexate) injection 15 mg/0.4 mL

Carton of 1 NDC 54436-015-01
Carton of 4 NDC 54436-015-04
Otrexup NDC 54436-015-02

Otrexup (methotrexate) injection 20 mg/0.4 mL

Carton of 1 NDC 54436-020-01
Carton of 4 NDC 54436-020-04
Otrexup NDC 54436-020-02

Otrexup (methotrexate) injection 25 mg/0.4 mL

Carton of 1 NDC 54436-025-01
Carton of 4 NDC 54436-025-04
Otrexup NDC 54436-025-02

Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). PROTECT FROM LIGHT.

Handling and Disposal Handle and dispose of Otrexup consistent with recommendations for handling and disposal of cytotoxic drugs.1

REFERENCES

1. “Hazardous Drugs”. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Mfd. For Antares Pharma, Inc. Ewing, NJ 08628. Issued: 10/2013

Last reviewed on RxList: 10/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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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.


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