Drug Info

Name: Orencia
Other brand Name(s):
Generic Name(s): Abatacept
Generic Ingredient(s):

Patient Information Sheet
Abatacept (marketed as Orencia)

This is a summary of the most important information about Orencia. For details, talk to your healthcare professional.

What Is Orencia?

Orencia is a medicine that is used to treat adults with moderate to severe rheumatoid arthritis (RA) who have not been helped by other medicines for RA. RA is a disease that causes pain and joint inflammation (tenderness and swelling). RA can also cause joint damage. Your healthcare professional has decided to treat you with Orencia because your disease is still active even though you may have tried other treatments.

Who Should Not Be Treated With Orencia?

You should not receive Orencia if you have ever had an allergic reaction to Orencia.

What Are The Risks?

The following are the major potential risks and side effects of Orencia therapy. However, this list is not complete.

The following are the major possible risks and side effects of Orencia therapy:

• Serious infections.
  • Patients taking Orencia are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi. Call your healthcare professional immediately if you feel sick or get any infection during treatment with Orencia.
• Allergic reactions.
  • These reactions are usually mild or moderate and include hives, swollen face, eyelids, lips, tongue, throat, or trouble breathing.
• Malignancies.
  • There have been rare cases of certain kinds of cancer in patients receiving Orencia. The role of Orencia in the development of cancer is not known.
• Some common side effects that may occur with Orencia include:
  • headache
  • upper respiratory tract infection
  • sore throat
  • nausea

What Should I Tell My Healthcare Professional?

Before you start taking Orencia, tell your healthcare professional if you:

• are taking a TNF blocker to treat RA. You may have a higher chance of getting a serious infection if you take Orencia with other biologic medications for RA.
• have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from Orencia. If you are unsure, please ask your healthcare professional.
• have an infection that won’t go away or a history of infections that keep coming back.
• have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB. If you develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever, night sweats) call your healthcare professional right away. Before you start Orencia, your healthcare professional may examine you for TB or perform a skin test.
• are scheduled to have surgery.
• recently received a vaccination or are scheduled for any vaccination.
• are trying to become pregnant or are already pregnant. It is not known if Orencia can harm your unborn baby.
• are breastfeeding. Orencia can pass into breast milk. You will need to decide to either breastfeed or receive treatment with Orencia, but not both.

Can Other Medicines Or Food Affect Orencia?

Orencia and certain other medicines may interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Taking Orencia with TNF blocker medications (Enbrel, Humira, Remicade) is not recommended.

How Should I Receive Orencia?

• Orencia will be given to you by a healthcare professional using an IV. This means the medicine will be given to you through a needle placed in a vein in your arm. It will take about 30 minutes to give you the full dose of medicine.
• You will receive your first dose of Orencia followed by additional doses at 2 and 4 weeks after the first dose. You will then receive a dose every 4 weeks.

FDA update: 02/15/2006

Name: Alrex
Other brand Name(s): Lotemax
Generic Name(s):  Loteprednol Etabonate
Generic Ingredient(s):

Loteprednol Etabonate (Marketed as Alrex)

What is Alrex used for? 

Alrex is used for the temporary relief of the itching and redness of the eye caused by seasonal allergies. Alrex should not be used to treat contact lens-related problems.

Who should not use Alrex?

You should not use Alrex if you have any of the following conditions:

Special Warnings for Alrex:

• Long-term use of Alrex or other eye drops that contain steroids may result in glaucoma, and cataracts. If you already have glaucoma, tell your doctor.
• Long-term use of Alrex or other eye drops that contain steroids may lower your ability to fight infections and may increase your chance of getting an eye infection.
• Using steroid eye drops may make viral diseases of the eye, such as herpes simplex, worse and last longer.
• Using steroid eye drops after cataract surgery may delay healing time.

General Precautions with Alrex:

• You should contact your doctor if pain develops, or if redness or itching gets worse.
• Tell your doctor if your symptoms do not get better within two days. He/she may want to re-evaluate your condition.
• You should not use Alrex longer than 10 days without having the pressure in your eye checked by your doctor.

What should I tell my doctor or healthcare provider?

Tell your doctor or healthcare provider if you:

• wear contact lenses because you should not wear contact lenses if your eyes are red.
• wear contact lenses and your eyes are not red. You should wait at least 10 minutes after using Alrex before putting in your contact lenses because Alrex contains a preservative that may be absorbed by the lens.

What are some possible side effects of Alrex? (This is NOT a complete list of side effects reported with Alrex. Your doctor can discuss with you a more complete list of side effects.)

• Increased pressure within the eye (see special warnings)
• Blurring of vision
• Burning when putting drops in the eye
• Swelling or discharge around the eyelids
• Dry eyes
• Tearing
• Sensation of having an object in your eye
• Itching
• Redness
• Increased sensitivity to light
• Headache
• Runny nose
• Sore throat

For more detailed information about Alrex, ask your healthcare provider.

Link to Alrex's Approved Labeling [PDF ]

FDA creation: July 24, 2006

Brand Name: Emtriva
Other brand Name(s):
Generic Name(s): Emtricitabine
Generic Ingredient(s):

Emtricitabine (marketed as Emtriva)

This is a summary of the most important information about Emtriva. For details, talk to your healthcare professional.

What is Emtriva used for?

Emtriva is a type of medicine called an HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitor (NRTI). Emtriva helps to block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. Emtriva is always used with other anti-HIV medicines to treat people with HIV infection. Emtriva is for patients over 3 months of age. Emtriva has not been studied fully in adults over age 65.

Emtriva does not cure HIV infection or AIDS. The long-term effects of Emtriva are not known at this time. Emtriva may lower the amount of HIV in the blood (viral load). Emtriva may also help to increase the number of T cells called CD4 cells. Lowering the amount of HIV in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). People taking Emtriva may still get opportunistic infections or other conditions that happen with HIV infection.

Emtriva does not lower your chances of passing HIV to other people through sexual contact, sharing needles, or being exposed to blood. For your health and the health of others, it is important to always practice safe sex and never use or share dirty needles.

It is very important that you see your healthcare provider regularly while taking Emtriva.

Who should not take Emtriva?

Do not take Emtriva if you are allergic to Emtriva or any of its ingredients.

Special Warnings with Emtriva:

• Some people who have taken medicines like Emtriva (a nucleoside analog) have developed a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital.
• Some people who have taken medicines like Emtriva have developed serious liver problems called hepatotoxicity, with liver enlargement and fat in the liver called steatosis.
• You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like Emtriva, for a long time.

General Precautions with Emtriva:

• Do not breast-feed.
• Avoid doing things that can spread HIV infection since Emtriva does not stop you from passing HIV infection to others.
• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have sex of any kind without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.

What should I tell my healthcare provider?

Tell your healthcare provider:

• if you are pregnant or planning to become pregnant.
• if you are breast-feeding.
• if you have kidney problems.
• if you have any liver problems including Hepatitis B Virus infection.
• about all your medical conditions.
• about all the medicines you take, such as prescription and non-prescription medicines and dietary supplements.

What are some possible side effects of Emtriva? (This is NOT a complete list of side effects reported with Emtriva. Your healthcare provider or pharmacist can discuss with you a more complete list of side effects.)

Serious side effects with Emtriva include:

• lactic acidosis
• serious liver problems
• “flare-ups” of hepatitis B virus infection. Patients with hepatitis B virus infection, who take Emtriva and then stop it, may get “flare-ups” of their hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Emtriva is not for the treatment of Hepatitis B Virus (HBV) infection.

Some common side effects with Emtriva include:

• changes in body fat distribution
• headache
• diarrhea
• nausea
• rash
• skin discoloration

The long-term effects of Emtriva are not known at this time.

For more detailed information about Emtriva, ask your healthcare provider or pharmacist.

Link to Emtriva's Approved Labeling

FDA Update: August 9, 2006

Brand Name: Emend
Other brand Name(s):
Generic Name(s): Aprepitant
Generic Ingredient(s):

Aprepitant (marketed as Emend)

This is a summary of the most important information about Emend. For details, talk to your healthcare professional.

What is Emend used for?

Emend is an antiemetic medicine for use in adult patients. An antiemetic is a medicine used to prevent and control nausea and vomiting. Emend is used:

• with other antiemetic medicines to prevent and control nausea and vomiting caused by your chemotherapy treatment.
• by itself to prevent nausea and vomiting after an operation.

Emend is not used to treat nausea and vomiting that you already have.

Who should not take Emend?

You should not take Emend if:

• you are taking any of the following medicines (taking Emend with these medicines could cause serious or life-threatening problems)
  • Orap (pimozide)
  • Seldane (terfenadine)
  • Hisminal (astemizole)
  • Propulsid (cisapride)
• are allergic to any of the ingredients in Emend.

What should I tell my doctor or healthcare provider?

Tell your healthcare provider:

• if you are trying to become pregnant, are already pregnant, or are breast-feeding.
• if you have or had liver problems.
• about all your medical problems.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of these products may affect how Emend works and Emend may affect how some medicines work.

Especially tell your healthcare provider if you are on:

• chemotherapy
• Coumadin (warfarin)
• birth control pills.

Emend may affect how these medicines work.

What are some possible side effects of Emend? (This list is NOT a complete list of side effects reported with Emend. Your healthcare provider or pharmacist can discuss with you a more complete list of side effects.)

The most common side effects with Emend are:

• tiredness
• nausea
• hiccups
• constipation
• diarrhea
• loss of appetite

For more detailed information about Emend, ask your healthcare provider or pharmacist.

Link to Emend's Approved Labeling and Patient Information

FDA Update: August 9, 2006

Brand Name: Aromasin
Other brand Name(s):
Generic Name(s): Exemestane
Generic Ingredient(s):

Exemestane (marketed as Aromasin)

This is a summary of the most important information about Aromasin. For details, talk to your healthcare professional.

What is Aromasin used for?

Aromasin is used to treat advanced breast cancer in postmenopausal women whose disease has gotten worse after treatment with tamoxifen. Postmenopausal women are women who have gone through the “change of life” and are no longer having menstrual cycles.

Aromasin is used to reduce the risk of breast cancer recurrence (coming back) in postmenopausal women with estrogen receptor positive early stage breast cancer who have received two to three years of tamoxifen and are switched to Aromasin to complete a total of five consecutive years of therapy.

The safety and effectiveness of Aromasin in women who can still have children (premenopausal) has not been determined.

General Precautions with Aromasin:

Do not take Aromasin if you are pregnant. Aromasin may cause birth defects or even death to an unborn baby. Aromasin has only been studied in postmenopausal women.

Tell your doctor if you have a history of liver or kidney problems.

What should I tell my doctor or healthcare provider?

Because certain other medications can interact with Aromasin, review all medications that you are taking with your healthcare provider, including those that you take without a prescription. It is important to avoid taking any medications containing estrogen along with Aromasin, because they may interfere with the action of Aromasin.

If you are breastfeeding and are accidentally exposed to Aromasin tell your doctor right away.

What are some possible side effects of Aromasin? (This is NOT a complete list of side effects reported with Aromasin. Your healthcare provider can discuss with you a more complete list of side effects.)

Side effects of Aromasin are generally mild to moderate. Side effects can include:

• Feeling tired
• Nausea
• Hot flashes
• Pain
• Depression
• Inability to sleep
• Anxiety
• Shortness of breath
• Dizziness
• Headache
• Swelling of arms and legs
• Vomiting
• Stomach pain
• Loss of appetite
• Coughing
• Flu-like symptoms
• High blood pressure
• Constipation

For more detailed information about Aromasin, ask your healthcare provider.

Link to Aromasin's Approved Labeling

FDA Update: August 21, 2006

Brand Name: Chantix
Other brand Name(s):
Generic Name(s): Varenicline
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

Varenicline (marketed as Chantix)

PDF Print Version

This is a summary of the most important information about Chantix. For details, talk to your healthcare professional.

What Is Chantix?

Chantix is a prescription medicine to help adults stop smoking.

Chantix has not been studied in children under 18 years of age. Chantix is not recommended for children under 18 years of age.

Who Should Not Take Chantix?

Do not take Chantix if you are allergic to anything in it.

What Are The Side Effects?

The following are common side effects of Chantix therapy. However, this list is not complete.

• nausea.
• changes in dreaming
• constipation
• gas
• vomiting

Tell your healthcare professional about side effects that bother you or that do not go away.

What Should I Tell My Healthcare Professional?

Before you start taking Chantix, tell your healthcare professional if you:

• have or had kidney problems, or get kidney dialysis
• are trying to become pregnant, are already pregnant, or are breast-feeding

Can Other Medicines Or Food Affect Chantix?

Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare professional if you take:

• insulin
• asthma medicines
• blood thinners

When you stop smoking, there may be a change in how these and other medicines work for you. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Should I Take Chantix?

• Choose a quit date when you will stop smoking.
• Start taking Chantix 1 week (7 days) before your quit date. This lets Chantix build up in your body. You can keep smoking during this time. Make sure that you try and stop smoking on your quit date. If you slip, try again. Some people need a few weeks for Chantix to work best.
• Take Chantix after eating and with a full (8 ounces) glass of water.
• Most people will keep taking Chantix for up to 12 weeks. If you have completely quit smoking by 12 weeks, ask your doctor if another 12 weeks of Chantix may help you stay cigarette-free.
• Chantix comes as a white tablet (0.5 mg) and a blue tablet (1 mg). You start with the white tablet and then usually go to the blue tablet. Follow the dosing schedule prescribed by your healthcare professional.

Link to Chantix's Approved Labeling

Brand Name: Campral
Other brand Name(s):
Generic Name(s): Acamprosate calcium
Generic Ingredient(s):

Consumer Information Sheet from the US Food and Drug Administration

What is Campral used for?

Campral is used to help patients with alcoholism stay alcohol-free after they have stopped drinking. Treatment with Campral should be part of a program that includes counseling and support. Campral has not shown to help patients who are still drinking at the start of treatment. Campral has not been studied in patients who abuse other substances in addition to alcohol.

Who should not take Campral?

Do not take Campral if you:

• are allergic to Campral or any of the ingredients in Campral
• have severe kidney problems

General Precautions with Campral:

• Campral does not get rid of or weaken alcohol withdrawal symptoms.
• Patients using Campral should be watched for symptoms of depression or thoughts of suicide.
• Campral may impair judgement, thinking, or motor skills. Do not drive a car or operate dangerous machines until you know how Campral affects you.

What should I tell my health care provider?

Tell your health care provider if you:

• have or had kidney problems

• are pregnant, are trying to become pregnant, or are breast-feeding

• startdrinking alcohol again

Campral has not been shown to interact with other medicines. However, it is always important to tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are some possible side effects of Campral? (This list is NOT a complete list of side effects reported with Campral. Your health care provider can discuss with you a more complete list of side effects.)

Some common side effects with Campral include:

• diarrhea
• sleep problems
• anxiety
• depression
• weakness

For more detailed information about Campral, ask your health care provider or pharmacist.

Campral's Approved Label

Posted by the FDA: 11/16/2004

Brand Name: Crestor
Other brand Name(s):
Generic Name(s): Rosuvastatin Calcium
Generic Ingredient(s):

Crestor (Rosuvastatin Calcium)

What Is Crestor?

Crestor is a medicine that lowers "bad" cholesterol and triglycerides and raises "good" cholesterol in the blood. Crestor is part of a treatment program that should also include a low-fat diet and exercise.

Who Should Not Take Crestor?

Do not take Crestor if you:

• Have liver problems or have persistently high liver enzymes

• Are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you get pregnant, stop Crestor and call your healthcare professional right away.

• Are breast-feeding. It is not known if Crestor can pass into your milk, and if it can harm your baby. You should choose to either take Crestor or breastfeed, but not both.

• Are allergic to Crestor or any of its ingredients

Crestor has not been studied in children.

What Are The Risks?

Crestor may cause rare, but serious, side effects including:

Muscle damage. Crestor can cause serious muscle damage that can lead to kidney damage. The risk of muscle damage may be increased by taking certain drugs. Crestor should be used with caution if you have kidney problems, advanced age, and hypothyroidism because you are at a greater risk of muscle damage. Tell your healthcare professional if you develop unexplained muscle pain, tenderness, or weakness while on Crestor, particularly if accompanied by malaise or fever.

Liver damage. Crestor can cause liver damage like other lipid lowering medicines. This risk may be increased when Crestor is used with certain medicines. Your healthcare professional may do blood tests to check your liver before you start taking Crestor, and while you take it. Crestor should be used with caution if you have a history of liver disease or drink substantial amounts of alcohol.
Other side effects include muscle pain, constipation, weakness, abdominal pain, and nausea

What Should I Tell My Healthcare Professional?

Before starting Crestor, tell your healthcare professional about all your medical conditions, including if you:

• Are pregnant or planning to become pregnant

• Are breast-feeding

• Have liver problems

• Have kidney problems

• Drink alcohol

Are There Any Interactions With Drugs Or Foods?

Tell your healthcare professional about all the medicines you take, including prescription and over the counter drugs, and supplements. Crestor and certain medicines may interact with each other causing serious side effects. Crestor and other medicines may affect each other, causing serious side effects. Especially tell your healthcare professional if you take:

• Cyclosporine (Gengraf, Neoral, Sandimmune)

• Warfarin (Coumadin)

• Gemfibrozil (Lopid)

• Drugs that may decrease the levels or activity of your body’s own steroid hormones. These drugs include ketoconazole (Nizoral), spironolactone (Aldactone), and cimetidine (Tagamet)

• Aluminum and magnesium hydroxide combination antacids (for example, Maalox)

How do I take Crestor?

• You should be placed on a standard lipid-lowering diet and an exercise routine before receiving Crestor and should continue these during treatment. Crestor can be taken as a single dose at any time of day, with or without food.

• The dose range for Crestor is 5 to 40 mg once daily. You should start on the lowest possible dose, and never start with 40 mg. After starting or changing your dose of Crestor, your lipid levels should be checked within 2 to 4 weeks and your dose adjusted as needed.

Brand Name: Gabitril
Other brand Name(s):
Generic Name(s): Tiagabine
Generic Ingredient(s):

Consumer Information Sheet from the US Food and Drug Administration

This is a summary of the most important information about Gabitril. For details, talk to your healthcare professional.

FDA ALERT – [02/18/2005] – FDA and the Maker of Gabitril are Discouraging the Use of Gabitril to Treat Conditions Other than Epilepsy.

• Seizures have occurred in patients taking Gabitril for conditions other than epilepsy

• Most of the seizures that have occurred in patients without a history of epilepsy have occurred soon after starting Gabitril, or soon after a dose increase. Some seizures occurred after several months of treatment. Some patients had seizures at a very low dose of Gabitril.

• Gabitril is only approved for use with other anti-epilepsy medicines to treat partial seizures in adults and children 12 years and older

• If you are taking Gabitril, you should not stop the drug on your own; you should speak to your healthcare professional about this as soon as you can.

The label for Gabitril has been changed to warn healthcare professionals and patients that these seizures can occur in patients without epilepsy.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

What is Gabitril?

Gabitril is an anti-epilepsy (seizure) drug. Gabitril is used together with other anti-epilepsy drugs to treat partial seizures in adults and children 12 years and older

Who Should Not Take Gabitril?

• The only use recommended in the labeling for Gabitril is treatment of seizures. (See "What is Gabitril?")

Healthcare professionals are allowed to, and sometimes do, prescribe drugs for uses that are not in the labeling. The maker of Gabitril is strongly discouraging Gabitril's use for any condition except for epilepsy because most of the reported seizures with Gabitril occurred in patients being treated for other conditions. However, if you are taking Gabitril for a condition other than epilepsy, you should not stop taking it on your own; you should speak to your healthcare professional as soon as you can.

What Are The Risks?

• Seizures in patients without epilepsy: See FDA Alert.

• Withdrawal seizures. Gabitril can increase seizures if it is stopped suddenly in patients with epilepsy. If you have epilepsy, and your healthcare professional has decided that you should stop taking Gabitril, it should be stopped slowly.

• Thinking and concentration problems, sleepiness and tiredness. Do not drive a car or operate dangerous machines until you know how Gabitril affects you.

• Serious rash. Gabitril may cause a serious and life-threatening rash.

• Other side effects include dizziness, lightheadedness, low energy, nausea, nervousness, irritability, tremors, and stomach pain.

• Tell your healthcare professional about any medical conditions you have, especially liver problems. Tell your healthcare professional if you are pregnant, planning to become pregnant, or breast-feeding

Are There Any Interactions With Drugs or Foods?

• Gabitril may interact with other medicines. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take, especially other medicines used for epilepsy.

How Do I Take Gabitril?

Gabitril is taken by mouth, with food, exactly as prescribed by your healthcare professional.

Brand Name: Provigil
Other brand Name(s):
Generic Name(s): Modafinil
Generic Ingredient(s):

Consumer Information Sheet from the US Food and Drug Administration

What is Provigil used for?

Provigil is used to improve wakefulness in people who have:

· excessive daytime sleepiness associated with narcolepsy.

· stopped breathing while sleeping or have difficulty breathing while sleeping (obstructive sleep apnea/hypopnea syndrome)

· shift work sleep disorder

General Precautions with Provigil:

Provigil can decrease the effectiveness of certain contraceptives including birth control pills and implantable contraceptives. If you are using these types of contraceptives while taking Provigil and for 1 month after you stop treatment with Provigil you should either use:

· an alternate birth control method, or

· another effective birth control method together with your current contraceptive.

Doses of your other medications may need to be adjusted or you may have to be monitored more closely.

Do not drive or operate other complex machinery until you know how Provigil affects your ability to function.

Avoid alcohol.

Call your health care provider if you develop a skin rash, hives, or any other allergic reactions.

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you:

• have any heart conditions (including valve problems, irregular heart beat, recent heart attack, or unstable chest pain)
• have a history of mental illness
• have liver problems
• are trying to become pregnant, are already pregnant, or are breast-feeding.

Review all medications that you are taking with your health care provider, including those that you take without a prescription, because certain other medications can interact with Provigil.

What are some possible side effects of Provigil? (This is not a complete list of side effects reported with Provigil. Your health care provider can discuss with you a more complete list of side effects.)

• headache
• infection
• nausea
• nervousness
• feeling anxious
• trouble sleeping

For more detailed information about Provigil, ask your health care provider.

Link to Provigil's Approved Labeling and Patient Information [PDF]