Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

NOVOLOG MIX 50/50 (BLA-021810)

(INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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11/15/2019 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

(Additions and/or revisions underlined)

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

6 Adverse Reactions

6.3 Postmarketing Experience

(Additions and/or revisions underlined)

Additional adverse reactions have been identified during post-approval use of NOVOLOG and NOVOLOG MIX 70/30. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. They include medication errors in which insulins with similar names have been accidentally substituted for each other.

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information for NovoLog Mix 50/50

(Additions and/or revisions underlined)

What is NovoLog® Mix 50/50?

NovoLog® Mix 50/50 is both a rapid-acting and long-acting man-made insulin.

NovoLog® Mix 50/50 comes in:

3 mL single-patient-use PenFill® cartridges.
3 mL single-patient-use NovoLog® Mix 50/50 FlexPen® Prefilled syringe.

How should I take NovoLog® Mix 50/50?

Read the instructions for use that come with your NovoLog® Mix 50/50 product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject NovoLog® Mix 50/50 before you start taking it.

Take NovoLog® Mix 50/50 exactly as prescribed. NovoLog® Mix 50/50 is injected right before a meal, up to three (3) times each day.
NovoLog® Mix 50/50 starts acting fast, so inject it up to 15 minutes before you eat a meal. Do not inject NovoLog® Mix 50/50 if you are not planning to eat within 15 minutes.
Inject NovoLog® Mix 50/50 under the skin of your stomach area, upper arms, or upper legs. NovoLog® Mix 50/50 may affect your blood sugar levels sooner if you inject it into the skin of your stomach area.
Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Other possible side effects include:

Serious allergic reaction (whole body allergic reaction). Get medical help right away if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
Reactions at the injection site (local allergic reaction). You may get redness, swelling and itching at the injection site. If you keep having skin reactions or they are serious, you may need to stop taking NovoLog® Mix 50/50 and take a different insulin. Do not inject insulin into a skin area that is red, swollen, or itchy.
Skin thickening or pits at the injection site (lipodystrophy) or lumps at the injection site (localized cutaneous amyloidosis).

11/15/2019 (SUPPL-19)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

(Additions and/or revisions underlined)

6 Adverse Reactions

6.3 Postmarketing Experience

(Additions and/or revisions underlined)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information for NovoLog Mix 50/50

(Additions and/or revisions underlined)

What is NovoLog® Mix 50/50?

NovoLog® Mix 50/50 is both a rapid-acting and long-acting man-made insulin.

NovoLog® Mix 50/50 comes in:

3 mL single-patient-use PenFill® cartridges.
3 mL single-patient-use NovoLog® Mix 50/50 FlexPen® Prefilled syringe.

How should I take NovoLog® Mix 50/50?

Take NovoLog® Mix 50/50 exactly as prescribed. NovoLog® Mix 50/50 is injected right before a meal, up to three (3) times each day.
NovoLog® Mix 50/50 starts acting fast, so inject it up to 15 minutes before you eat a meal. Do not inject NovoLog® Mix 50/50 if you are not planning to eat within 15 minutes.
Inject NovoLog® Mix 50/50 under the skin of your stomach area, upper arms, or upper legs. NovoLog® Mix 50/50 may affect your blood sugar levels sooner if you inject it into the skin of your stomach area.
Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

Other possible side effects include:

Serious allergic reaction (whole body allergic reaction). Get medical help right away if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
Reactions at the injection site (local allergic reaction). You may get redness, swelling and itching at the injection site. If you keep having skin reactions or they are serious, you may need to stop taking NovoLog® Mix 50/50 and take a different insulin. Do not inject insulin into a skin area that is red, swollen, or itchy.
Skin thickening or pits at the injection site (lipodystrophy) or lumps at the injection site (localized cutaneous amyloidosis).

08/07/2019 (SUPPL-17)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; extensive changes – please refer to labeling)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

Risk Summary

There are no data on the presence of NOVOLOG MIX 50/50 in human milk, the effects on the breastfed infant, or the effect on milk production. One small published study reported that exogenous insulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NOVOLOG MIX 50/50, and any potential adverse effects on the breastfed infant from NOVOLOG MIX 50/50 , or from the underlying maternal condition.

11/21/2017 (SUPPL-1)

Approved Drug Label (PDF)

Other

(Physician Labeling Rule (PLR) conversion; please refer to label)