NOVOLIN 70/30- human insulin injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)

Available from:

Novo Nordisk

INN (International Name):

INSULIN HUMAN

Composition:

INSULIN HUMAN 100 [USP'U] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC DRUG

Therapeutic indications:

NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. NOVOLIN 70/30 is contraindicated: Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general

Product summary:

NOVOLIN 70/30 injectable suspension is 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0169-1837-11 ReliOn® brand NDC 0169-1837-02 3 mL single-patient-use FlexPen NDC 0169-3007-15 ReliOn® brand NDC 0169-3007-25 The NOVOLIN 70/30 FlexPen dials in 1-unit increments. Dispense in the original sealed carton with the enclosed Instructions for Use. Do not expose NOVOLIN 70/30 vials and NOVOLIN 70/30 FlexPen to excessive heat or light. Do not freeze. Do not use after the expiration date. NOVOLIN 70/30 FlexPen must never be shared between patients, even if the needle is changed. Always remove and discard the needle after each injection from the NOVOLIN 70/30 FlexPen and store without a needle attached. Patients using NOVOLIN 70/30 vials, must never share needles or syringes with another person. Always use a new disposable syringe or needle for each injection to prevent contamination. Table 2: Storage Conditions and Expiration Dates for NOVOLIN 70/30 Not In-use (Unopened) Refrigerated (36°F - 46°F [2°C - 8°C]) Not In-use (Unopened) Room Temperature (see temperature below) In-use (Opened) Room Temperature (see temperature below) 10 mL multiple-dose vial Until expiration date 42 days up to 77°F (25°C) 42 days up to 77°F (25° C) (Do not refrigerate) 3 mL single-patient-use FlexPen Until expiration date 28 days up to 86°F (30°C) 28 days up to 86°F (30°C) (Do not refrigerate)

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVOLIN 70/30- HUMAN INSULIN INJECTION, SUSPENSION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLIN 70/30 SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOVOLIN 70/30.
NOVOLIN 70/30 (INSULIN ISOPHANE HUMAN AND INSULIN HUMAN) INJECTABLE
SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
NOVOLIN 70/30 is a mixture of human insulin isophane, an
intermediate-acting human insulin, and human
insulin, a short-acting human insulin, indicated to improve glycemic
control in adults and pediatric patients
with diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions observed with NOVOLIN 70/30 include hypoglycemia,
allergic reactions, injection site
reactions, lipodystrophy, weight gain and edema. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVO NORDISK INC. AT
1-800-727-6500 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2022
®
See Full Prescribing Information for important administration
instructions. (2.1)
Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks
and rotate injection sites to
reduce risk of lipodystrophy and localized cutaneous amyloidosis.
(2.1)
Individualize and adjust dosage based on metabolic needs, blood
glucose monitoring results and
glycemic control goal. (2.2)
Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes prior to
start of meal. (2.2)
NOVOLIN 70/30 is typically dosed twice daily (with each dose intended
to cover 2 meals or a meal and
a snack). (2.2)
10 mL multiple-dose vial (3)
3 mL single-patient-use NOVOLIN 70/30 FlexPen prefilled pen (3)
During episodes of hypoglycemia (4)
Hypersensitivity to NOVO