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.

ZERIT (NDA-020412)

(STAVUDINE)

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

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12/17/2018 (SUPPL-41)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label foe more information)

8.2 Lactation

(PLLR conversion)

Risk Summary

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.

Based on limited data, stavudine has been detected in human milk. No data are available regarding the effects of stavudine on the breastfed infant, or the effects on milk production.

Because of the potential for (1) HIV transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants) and (3) adverse reactions in breastfed infants similar to those seen in adults, instruct mothers not to breastfeed if they are receiving ZERIT.

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

Medication Guide

(Updated with didanosine information to be consistent with the Prescribing Information, please refer to label)

PATIENT COUNSELING INFORMATION

(additions underlined)

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Lactic Acidosis

Inform patients of the importance of early recognition of symptoms of symptomatic hyperlactatemia or lactic acidosis syndrome, which include unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, and motor weakness. Patients in whom these symptoms develop should seek medical attention immediately. Discontinuation of ZERIT therapy may be required. Advise pregnant individuals of the potential risks of lactic acidosis syndrome/hepatic steatosis syndrome.

…

Other

(PLLR conversion)

12/19/2017 (SUPPL-40)

Approved Drug Label (PDF)

Boxed Warning

WARNING: LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS; PANCREATITIS

(Additions and/or revisions are underlined)

…Fatal lactic acidosis has been reported in pregnant women who received the combination of ZERIT and didanosine with other antiretroviral agents. Coadministration of ZERIT and didanosine is contraindicated because of increased risk of serious and/or life-threatening events. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

4 Contraindications

(Additions and/or revisions are underlined)

…

Co-administration of ZERIT with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis.

5 Warnings and Precautions

5.1 Lactic Acidosis/Severe Hepatomegaly with Steatosis

(Additions and/or revisions are underlined)

…Coadministration of ZERIT and didanosine is contraindicated.

5.2 Hepatic Toxicity

(Additions and/or revisions are underlined)

…Coadministration of ZERIT and didanosine is contraindicated; and the combination of ZERIT and hydroxyurea should be avoided.

5.4 Pancreatitis

(Additions and/or revisions are underlined)

…Coadministration of ZERIT and didanosine is contraindicated…

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

…The combination of stavudine and didanosine is contraindicated…

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

…

Hepatic Toxicity

Inform patients that hepatotoxicity, which may be fatal, may occur in patients treated with ZERIT in combination with didanosine and hydroxyurea. ZERIT is contraindicated in combination with didanosine. Avoid coadministration of ZERIT with hydroxyurea.

…

Pancreatitis

…ZERIT is contraindicated in combination with didanosine. Closely monitor patients for symptoms of pancreatitis such as severe abdominal pain, nausea and vomiting, and fever.

Lipoatrophy

Inform patients that loss of body fat (e.g., loss of fat from arms, legs, or face) may occur in individuals receiving ZERIT…

Pregnancy Registry

Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnancy women exposed to ZERIT.

Lactation

Inform patients that it is not known if ZERIT can be passed to the baby by breast milk and whether it could harm the baby. Advise mothers with HIV-1 not breastfeed because HIV-1 can be passed to the baby in breast milk.

Sucrose in ZERIT for Oral Solution

Inform patients with diabetes that ZERIT for oral solution contains 50 mg of sucrose per mL.

Dosing Information

Instruct patients not to miss a dose but if they do, patients should take ZERIT as soon as possible. Inform patients that it is important to take ZERIT on a regular dosing schedule and to avoid missing doses as it can result in development of resistance.

…

Medication Guide

(Additions and/or revisions are underlined)

What is the most important information I should know about ZERIT?

ZERIT can cause serious side effects, including:

Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take ZERIT or similar medicines (nucleoside analogues). Lactic acidosis is a serious medical emergency that can lead to death.
Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
- feel very weak or tired
- weight loss
Severe liver problems. Severe liver problems, including liver failure can happen in people who take ZERIT. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Taking ZERIT with medicines that contain didanosine or hydroxyurea may increase your risk for liver problems.
Call your healthcare provider right away if you have any of the following symptoms of liver problems:

dark or “tea-colored” urine
pain, aching, or tenderness on the right side of your stomach area
light colored stools (bowel movements)
You may be more likely to get lactic acidosis or severe liver problems if you are female, are very overweight (obese), or have been taking nucleoside analogue medicines for a long time.

Neurologic problems including weakness of your legs, feet, arms, or hands (motor weakness) and numbness, tingling or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy can be common and severe, and happens more often in people who have advanced HIV-1 disease, have a history of peripheral neuropathy, or in people who take other medicines that can cause peripheral neuropathy. In some cases, symptoms of neurologic problems may continue, worsen or temporarily worsen after you stop treatment with ZERIT.
Neurologic problems can be difficult to notice in children who take ZERIT. Ask your child’s healthcare provider for the signs and symptoms of neurologic problems in children.
Inflammation of your pancreas (pancreatitis) can happen in people who take ZERIT in combination with didanosine and can lead to death.
Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:

severe stomach (abdomen) pain

For more information about side effects, see “What are the possible side effects of ZERIT?”

What is ZERIT?

ZERIT is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus (HIV)-1 infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Do not take ZERIT if you:

take a medicine that contains didanosine.

Before taking ZERIT, tell your healthcare provider about all of your medical conditions, including if you:

have or had liver problems, including hepatitis C virus infection
are receiving dialysis
have or had numbness, tingling, or pain in the hands or feet (peripheral neuropathy)
have diabetes. ZERIT for oral solution contains 50 mg of sucrose (sugar) per mL
have diabetes mellitus. ZERIT for Oral Solution contains 50 mg of sucrose (sugar) per mL.

Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines, including ZERIT during pregnancy…

are breastfeeding or plan to breastfeed. Do not breastfeed if you take ZERIT.

You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
It is not known if ZERIT can pass into your breast milk and if it could harm your baby. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a medicine called hydroxyurea.

Some medicines interact with ZERIT. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with ZERIT.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ZERIT with other medicines.
How should I take ZERIT?

ZERIT should be taken every 12 hours.
Shake the bottle of ZERIT oral solution well before measuring each dose. Use the measuring cup provided by your pharmacist to give a dose of ZERIT oral solution.
Do not miss a dose of ZERIT. If you miss a dose of ZERIT, take it as soon as possible.
It is important to take ZERIT on a regular schedule. The virus in your blood may increase and the virus may become harder to treat if you miss doses.
If you take too much ZERIT, contact a poison control center or go to the nearest hospital emergency room right away.
What should I avoid while taking ZERIT?
Avoid drinking alcohol while taking ZERIT. Alcohol may increase your risk of side effects during treatment with ZERIT.
What are the possible side effects of ZERIT?
ZERIT can cause serious side effects including:

Loss of body fat (lipoatrophy) from the arms, legs, or face. Loss of body fat (lipoatrophy) happens more often in people who take ZERIT than in people who take other similar HIV-1 medicines.
Changes in your immune system (immune reconstitution syndrome) can happen when you start taking HIV- 1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
General information about the safe and effective use of ZERIT.
…You can ask your pharmacist or healthcare provider for information about ZERIT that is written for health professionals.