Drug Safety-related Labeling Changes (SrLC)

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VIDEX EC (NDA-021183)

(DIDANOSINE)

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

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12/17/2018 (SUPPL-29)

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 didanosine 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 EC.

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

Inform 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-28)

Approved Drug Label (PDF)

Boxed Warning

(Additions and/or revisions are underlined)

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Coadministration of VIDEX EC 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 EC is contraindicated when coadministered with the following medications:

  • Stavudine- 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)

…Patients treated with VIDEX EC in combination with stavudine may be at increased risk for pancreatitis; the coadministration of VIDEX EC and stavudine is contraindicated.

5.2 Lactic Acidosis/Severe Hepatomegaly with Steatosis

(Additions and/or revisions are underlined)

Coadministration of VIDEX EC and stavudine is contraindicated

5.3 Hepatic Toxicity

(Additions and/or revisions are underlined)

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

5.8 Lipoatrophy

(Newly added subsection)

Treatment with VIDEX EC 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 EC treatment is stopped. Patients receiving VIDEX EC 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 6: Predicted Drug Interactions with VIDEX EC (Table has been revised; please refer to label)

8 Use in Specific Populations

8.1 Pregnancy

(Additions and/or revisions are underlined)

Coadministration of VIDEX EC 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)

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

 

Retinal Changes and Optic Neuritis

Inform patients that retinal changes and optic neuritis, which may result in blurred vision, have been reported in adult and pediatric patients. Advise patients to have regular eye exams while taking VIDEX EC

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 EC. Monitor patients receiving VIDEX EC to monitor for clinical signs and symptoms of lipoatrophy. Patients should be routinely questioned about body changes related to lipoatrophy

Drug Interactions

VIDEX EC 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 EC toxicities. Patients should avoid alcohol with VIDEX EC

Pregnancy Registry

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

Lactation

Inform patients that it is not known if VIDEX EC 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 swallow the capsule whole on an empty stomach and to not open the capsule.

Inform patients that it is important to take VIDEX EC 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 VIDEX EC?

VIDEX EC can cause serious side effects, including:

  • Inflammation of your pancreas (pancreatitis) can happen in people who take VIDEX EC and can lead to death. People who take VIDEX EC in combination with the medicine stavudine may be at an increased risk for pancreatitis. Do not take VIDEX EC 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 EC or similar medicines (nucleoside analogues). Lactic acidosis is a serious medical emergency that can lead to death. There have been deaths reported in pregnant women who get lactic acidosis after taking VIDEX EC and ZERIT (stavudine). Do not take VIDEX EC 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 EC…Taking VIDEX EC 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 EC?”.

      What is VIDEX EC?

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

      Do not take VIDEX EC if you take:

  • allopurinol

  • ribavirin

  • stavudine

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

  • have or had problems with your pancreas

  • are receiving dialysis

  • drink alcoholic beverages

    Talk with your healthcare provider about the best way to feed 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 EC

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

  • 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 EC with other medicines.

    How should I take VIDEX EC?

  • Do not miss a dose of VIDEX EC. If you miss a dose of VIDEX EC, take it as soon as possible.

  • It is important to take VIDEX EC 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 EC?

    VIDEX EC 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 EC 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. Tell your healthcare provider if you get numbness, tingling, or pain in your hands or feet during treatment with VIDEX EC.

  • Vision changes. Call your healthcare provider if you have changes in vision, such as blurred vision. You should have regular eye exams while taking VIDEX EC.

  • Loss of body fat (lipoatrophy) can happen with VIDEX use. These changes may include less fat in your legs, arms, face.

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.

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