VIDEX EC (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

VIDEX EC (didanosine, USP) Delayed-Release Capsules are white, opaque capsules that are packaged in bottles with child-resistant closures as described in Table 14.

Table 14: VIDEX EC Delayed-Release Capsules

125 mg capsule imprinted with “BMS 125 mg 6671” in Tan

NDC No. 0087-6671-17

30 capsules/bottle

200 mg capsule imprinted with “BMS 200 mg 6672” in Green

NDC No. 0087-6672-17

30 capsules/bottle

250 mg capsule imprinted with “BMS 250 mg 6673” in Blue

NDC No. 0087-6673-17

30 capsules/bottle

400 mg capsule imprinted with “BMS 400 mg 6674” in Red

NDC No. 0087-6674-17

30 capsules/bottle

Storage

The capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature).

17 PATIENT COUNSELING INFORMATION

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

Pancreatitis

Inform patients that a serious toxicity of VIDEX EC, used alone and in combination regimens, is pancreatitis, which may be fatal [see Warnings and Precautions (5.1) ].

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 [see Contraindications (4), Warnings and Precautions (5.2) and Use in Specific Populations (8.1)].

Hepatic Toxicity

Inform patients that hepatotoxicity, including fatal hepatic adverse events, has been reported in patients with preexisting liver dysfunction. The safety and efficacy of VIDEX EC have not been established in HIV-infected patients with significant underlying liver disease. [see Warnings and Precautions (5.3)].

Non-cirrhotic Portal Hypertension

Inform patients that non-cirrhotic portal hypertension has been reported in patients taking VIDEX EC, including cases leading to liver transplantation or death. [see Warnings and Precautions (5.4)].

Peripheral Neuropathy

Inform patients that peripheral neuropathy, manifested by numbness, tingling, or pain in hands or feet, may develop during therapy with VIDEX EC (didanosine). Instruct patients that peripheral neuropathy occurs with greatest frequency in patients with advanced HIV-1 disease or a history of peripheral neuropathy, and that discontinuation of VIDEX EC may be required if toxicity develops [see Warnings and Precautions (5.5)].

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 [see Warnings and Precautions (5.6)].

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 [see Warnings and Precautions (5.7)].

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 [see Warnings and Precautions (5.8)].

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 [see Contraindications (4), Drug Interactions (7)].

Pregnancy Registry

Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant individuals exposed to VIDEX EC [see Use in Specific Populations (8.1) ].

Lactation

Advise mothers with HIV-1 not to breastfeed because HIV-1 can be passed to the baby in breast milk. [see Use in Specific Populations (8.2)].

Dosing Information

Instruct patients to swallow the capsule whole on an empty stomach and to not open the capsule.

Instruct patients not to miss a dose but if they do, patients should take VIDEX EC as soon as possible. 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.

Revised: December 2019

Medication Guide


VIDEX EC (VY-dex Ee-see)
(didanosine, USP)
Delayed-Release CapsulesEnteric-Coated Beadlets

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
  • nausea and vomiting
  • swelling of your stomach
  • fever
  • 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 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:

  • feel weak or tired
  • feel cold, especially in your arms and legs
  • have unusual (not normal) muscle pain
  • feel dizzy or light-headed
  • have trouble breathing
  • have a fast or irregular heartbeat
  • have stomach pain with nausea and vomiting
  • weight loss
  • Severe liver problems, including liver failure, can happen in people who take VIDEX EC. Your liver may become large (hepatomegaly), you may develop fat in the liver (steatosis), or you may have high blood pressure in the large vein of the liver (portal hypertension). Severe liver problems can lead to liver transplantation or death in some people taking 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:

  • yellowing of your skin or the white of your eyes (jaundice)
  • dark or “tea-colored” urine
  • light colored stools (bowel movements)
  • loss of appetite
  • nausea
  • 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?

VIDEX EC 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 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
  • have or had kidney problems
  • have or had liver problems, including hepatitis
  • have or had numbness, tingling, or pain in the hands or feet (peripheral neuropathy)
  • are receiving dialysis
  • drink alcoholic beverages
  • are pregnant or plan to become pregnant. It is not known if VIDEX EC will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines, including VIDEX EC during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take VIDEX EC.
  • 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 VIDEX EC 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 you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.
Some medicines interact with VIDEX EC. 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 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?

  • Take VIDEX EC exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much VIDEX EC to take and when to take it.
  • Take VIDEX EC on an empty stomach.
  • Take VIDEX EC capsules whole. If you cannot swallow VIDEX EC capsules whole, tell your healthcare provider. You may need a different medicine.
  • Your healthcare provider may change your dose. Do not change your dose of VIDEX EC without talking to your healthcare provider.
  • 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.
  • Your healthcare provider may lower your dosage of VIDEX EC if your kidneys are not working well.
  • If you take too much VIDEX EC, go to the nearest emergency room right away.

What are the possible side effects of VIDEX EC? VIDEX EC can cause serious side effects, including:

  • See “What is the most important information I should know about VIDEX EC?”
  • 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.
  • Changes in your immune system (immune reconstitution syndrome). 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 if you start having new or worse symptoms of infection after you start taking HIV medicine.
  • Loss of body fat (lipoatrophy) can happen with VIDEX use. These changes may include less fat in your legs, arms, face, and buttocks.

The most common side effects of VIDEX EC include:

  • diarrhea
  • rash
  • nausea
  • vomiting
  • headache

These are not all the possible side effects of VIDEX EC.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VIDEX EC?

  • Store VIDEX EC capsules in a tightly closed container between 59 °F to 86 °F (15 °C to 30 °C)

Keep VIDEX EC and all medicines out of the reach of children.

General information about the safe and effective use of VIDEX EC.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIDEX EC for a condition for which it was not prescribed. Do not give VIDEX EC to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about VIDEX EC that is written for health professionals.

What are the ingredients in VIDEX EC?
Active Ingredients: didanosine, USP
Inactive Ingredients: carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc
Capsule shell: gelatin, and titanium dioxide.

VIDEX® EC is a registered trademark of Bristol-Myers Squibb Company. Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA

For more information, go to www.bms.com/products/Pages/prescribing.aspx or call 1-800-321-1335.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised December 2018

VIDEX EC 125 mg Representative Packaging

See HOW SUPPLIED section for a complete list of available packages of VIDEX EC.

30 Capsules NDC 0087-6671-17

125 mg

VIDEX® EC
(didanosine, USP)
delayed-release capsules
enteric-coated beadlets

Detach and dispense
the accompanying
Medication Guideto the patient.

Rx only

PRINCIPAL DISPLAY PANEL -- 125 mg label
(click image for full-size original)

VIDEX EC 200 mg Representative Packaging

30 Capsules NDC 0087-6672-17

200 mg

VIDEX® EC
(didanosine, USP)
delayed-release capsules
enteric-coated beadlets

Detach and dispense
the accompanying
Medication Guideto the patient.

Rx only

PRINCIPAL DISPLAY PANEL -- 200 mg label
(click image for full-size original)

VIDEX EC 250 mg Representative Packaging

30 Capsules NDC 0087-6673-17

250 mg

VIDEX® EC
(didanosine, USP)
delayed-release capsules
enteric-coated beadlets

Detach and dispense
the accompanying
Medication Guideto the patient.

Rx only

PRINCIPAL DISPLAY PANEL -- 250 mg label
(click image for full-size original)

VIDEX EC 400 mg Representative Packaging

30 Capsules NDC 0087-6674-17

400 mg

VIDEX® EC
(didanosine, USP)
delayed-release capsules
enteric-coated beadlets

Detach and dispense
the accompanying
Medication Guideto the patient.

Rx only

PRINCIPAL DISPLAY PANEL -- 400 mg label
(click image for full-size original)
VIDEX EC didanosine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0087-6671
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
didanosine (didanosine) didanosine 125 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
diethyl phthalate
methacrylic acid — methyl methacrylate copolymer (1:2)
sodium hydroxide
sodium starch glycolate type a potato
talc
GELATIN, UNSPECIFIED
titanium dioxide
Product Characteristics
Color white (opaque) Score no score
Shape capsule Size 16mm
Flavor Imprint Code BMS;125;mg;6671
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0087-6671-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021183 10/31/2000 10/31/2021
VIDEX EC didanosine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0087-6672
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
didanosine (didanosine) didanosine 200 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
diethyl phthalate
methacrylic acid — methyl methacrylate copolymer (1:2)
sodium hydroxide
sodium starch glycolate type a potato
talc
GELATIN, UNSPECIFIED
titanium dioxide
Product Characteristics
Color white (opaque) Score no score
Shape capsule Size 18mm
Flavor Imprint Code BMS;200;mg;6672
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0087-6672-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021183 10/31/2000 10/31/2021
VIDEX EC didanosine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0087-6673
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
didanosine (didanosine) didanosine 250 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
diethyl phthalate
methacrylic acid — methyl methacrylate copolymer (1:2)
sodium hydroxide
sodium starch glycolate type a potato
talc
GELATIN, UNSPECIFIED
titanium dioxide
Product Characteristics
Color white (opaque) Score no score
Shape capsule Size 19mm
Flavor Imprint Code BMS;250;mg;6673
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0087-6673-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021183 10/31/2000 10/31/2021
VIDEX EC didanosine capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0087-6674
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
didanosine (didanosine) didanosine 400 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
diethyl phthalate
methacrylic acid — methyl methacrylate copolymer (1:2)
sodium hydroxide
sodium starch glycolate type a potato
talc
GELATIN, UNSPECIFIED
titanium dioxide
Product Characteristics
Color white (opaque) Score no score
Shape capsule Size 22mm
Flavor Imprint Code BMS;400;mg;6674
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0087-6674-17 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021183 10/31/2000 10/31/2021
Labeler — Bristol-Myers Squibb Company (102826703)

Revised: 12/2020 Bristol-Myers Squibb Company

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