Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

VIDEX (NDA-020156)

(DIDANOSINE)

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

Download Data

Expand all

12/17/2018 (SUPPL-54)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

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

8.2 Lactation

(PLLR conversion)

Risk Summary

The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. It is not known whether VIDEX is present in human breast milk, affects human milk production, or has effects on the breastfed infant. When administered to lactating rats, didanosine was present in milk (see Data).

Because of the potential for (1) HIV-1 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 VIDEX.

Data

Didanosine and its metabolites were excreted into the milk of lactating rats following a single oral dose of 50 mg per kg on lactation Day 14, with milk concentrations 5 times that of maternal plasma concentrations at 8 and 24 hours post-dose.

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

Medication Guide

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

PATIENT COUNSELING INFORMATION

(additions underlined)

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Advise patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Advise pregnant individuals of the potential risks of lactic acidosis syndrome/hepatic steatosis syndrome.

Other

 (PLLR conversion)

01/25/2018 (SUPPL-53)

Approved Drug Label (PDF)

Boxed Warning

(Additions and/or revisions are underlined)

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX and stavudine 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 occurs.

4 Contraindications

(Additions and/or revisions are underlined)

Videx is contraindicated when coadministered with the following medications:

Stavudine: Coadministration of didanosine and stavudine is contraindicated because of the potential for serious and/or life-threatening events notably pancreatitis, lactic acidosis, hepatotoxicity, and peripheral neuropathy.

5 Warnings and Precautions

5.1 Pancreatitis

(Additions and/or revisions are underlined)

Coadministration of VIDEX with stavudine is contraindicated.

5.2 Lactic Acidosis/Severe Hepatomegaly with Steatosis

(Additions and/or revisions are underlined)

Coadministration of VIDEX and stavudine is contraindicated

5.3 Hepatic Toxicity

(Additions and/or revisions are underlined)

Coadministration of VIDEX and stavudine is contraindicated; the combination of VIDEX and hydroxyurea should be avoided.

5.8 Lipoatrophy

(Newly added subsection)

Treatment with VIDEX has been associated with loss of subcutaneous fat, which is most evident in the face, limbs, and buttocks. The incidence and severity of lipoatrophy are related to cumulative exposure, and is often not reversible when VIDEX treatment is stopped. Patients receiving VIDEX should be frequently examined and questioned for signs of lipoatrophy, and if feasible therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy.

7 Drug Interactions

7.2 Predicted Drug Interactions

Table 9: Predicted Drug Interactions with VIDEX (Table has been revised; please refer to label)

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

…The combination of VIDEX and stavudine is contraindicated

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

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Pancreatitis

VIDEX is contraindicated in combination with stavudine. Closely monitor patients for symptoms of pancreatitis.

Hepatic Toxicity

VIDEX is contraindicated in combination with stavudine. Avoid the combination of VIDEX with hydroxyurea.

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.

Lipoatrophy

Inform patient that loss of body fat (e.g., from arms, legs, or face) may occur in individuals receiving antiretroviral therapy including VIDEX. Monitor patients receiving VIDEX to monitor for clinical signs and symptoms of lipoatrophy. Patients should be routinely questioned about body changes related to lipoatrophy.

Drug Interactions

VIDEX may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription of non-prescription medication or herbal products, including alcohol, which may exacerbate VIDEX toxicities.

Pregnancy Registry

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

Lactation

Inform patients that it is not known if VIDEX 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.

Dosing Information

Instruct patients to take VIDEX on an empty stomach at least 30 minutes before or 2 hours after eating.

Inform patients that it is important to take VIDEX on a regular dosing schedule

Medication Guide

(Additions and/or revisions are underlined)

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

VIDEX can cause serious side effects, including:

  • Inflammation of your pancreas (pancreatitis) can happen in people who take VIDEX and can lead to death. People who take VIDEX in combination with the medicine stavudine may be at an increased risk for pancreatitis. Do not take VIDEX with stavudine.

    Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:

    • severe stomach (abdomen) pain

  • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take VIDEX or similar medicines (nucleoside analogues)…There have been deaths reported in pregnant women who get lactic acidosis after taking VIDEX and ZERIT (stavudine). Do not take VIDEX with stavudine.

  • Call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis:

    • weight loss

  • Severe liver problems, including liver failure, can happen in people who take VIDEX… Taking VIDEX with medicines that contain hydroxyurea or stavudine may increase your risk for liver problems.

    You may be more likely to get lactic acidosis or severe liver problems if you are a female, are very overweight (obese), or have been taking nucleoside analogue medicines for a long time.

    Call your healthcare provider right away if you have any of the following symptoms of severe liver problems:

  • dark or “tea-colored” urine

  • light-colored stools (bowel movements)

  • pain, aching, or tenderness on the right side of your stomach area

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

    What is VIDEX?

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

    Do not take VIDEX if you take a medicine that contains:

  • allopurinol

  • ribavirin

  • stavudine

    Before you take VIDEX, tell your healthcare provider about all of your medical conditions, including if you:

  • are receiving dialysis

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

    • It is not known if VIDEX can pass into your breast milk and if it could harm your baby.

      Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

      Some medicines interact with VIDEX

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with VIDEX.

  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take VIDEX with other medicines.

    How should I take VIDEX?

  • Your healthcare provider may change your dose if you have certain side effects. Do not change your dose of VIDEX without talking to your healthcare provider.

  • Do not miss a dose of VIDEX

  • It is important to take VIDEX on a regular schedule. The virus in your blood may increase and the virus may become harder to treat if you miss doses.

    What are the possible side effects of VIDEX?

    VIDEX can cause serious side effects, including:

  • Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common during treatment with VIDEX and can be severe. Peripheral neuropathy happens more often in people who have advanced HIV-1 disease, have a history of peripheral neuropathy, or in people who are being treated with medicines that can cause neurologic problems.

  • Loss of body fat (lipoatrophy) from the arms, legs, or face can happen during treatment with VIDEX. Your healthcare provider will monitor you for changes in your body fat. It is important to tell your healthcare provider if you notice any changes.

    General information about the safe and effective use of VIDEX

    Do not give VIDEX to other people, even if they have the same symptoms that you have. It may harm them

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English