New PLR Articles Directory Kentucky: Zelboraf

Generic Name: vemurafenib (Oral route)

vem-ue-RAF-e-nib

Commonly used brand name(s)

In the U.S.

Zelboraf

Available Dosage Forms:

Tablet

Uses For Zelboraf

Vemurafenib is used to treat melanoma (a type of skin cancer) that has spread or that cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E mutation. Your doctor will use a special test to look for this mutation. Vemurafenib belongs to the group of medicines called antineoplastics (cancer medicines).

This medicine is available only with your doctor's prescription.

Before Using Zelboraf

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vemurafenib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vemurafenib in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., skin problems, decreased appetite, fast heartbeat, nausea, or swelling of the hands, feet, or legs) which may require caution in patients receiving vemurafenib.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride

Dronedarone

Levomethadyl

Mesoridazine

Posaconazole

Saquinavir

Sparfloxacin

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azithromycin

Carbamazepine

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Cyclosporine

Dasatinib

Desipramine

Dihydroergotamine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Ergotamine

Erythromycin

Fentanyl

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imipramine

Indinavir

Itraconazole

Ketoconazole

Lapatinib

Levofloxacin

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nefazodone

Nelfinavir

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Phenobarbital

Phenytoin

Pimozide

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Rifabutin

Rifampin

Rifapentine

Ritonavir

Salmeterol

Sirolimus

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tacrolimus

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Theophylline

Tizanidine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Dextromethorphan

Midazolam

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

Proper Use of Zelboraf

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablet):
- For melanoma (skin cancer):
  - Adults—960 milligrams (four 240 mg tablets) two times a day. The first dose should be taken in the morning, and the second dose in the evening. The two doses should be taken 12 hours apart.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose or forget to use this medicine, you may still take it up to 4 hours before your next regular dose time. If it is less than 4 hours until your next dose, skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Zelboraf

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC). This is more likely to occur if you are more than 65 years of age, have too much sun exposure, or a history of skin cancer. Your doctor may want your skin to be tested and checked for any new skin lesions before treatment and every 2 months while you are using this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; lightheadedness or dizziness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (e.g., liver enzymes and bilirubin).

This medicine may make your skin more sensitive to sunlight. Avoid overexposing your skin to sunlight. Use sunscreen or sunblock lotions and lip balms with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zelboraf Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision or other change in vision

chills

cough

diarrhea

dizziness

eye pain

fainting

fast or irregular heartbeat

fever

increased sensitivity of the skin to sunlight

itching

joint or muscle pain

lump or growth on the skin

pain in the ankles or knees

painful, red lumps under the skin, mostly on the legs

paralysis of the nerves

rapid weight gain

rash with flat lesions or small raised lesions on the skin

red skin lesions, often with a purple center

red, irritated eyes

redness or other discoloration of the skin

redness, soreness, swelling, or itching skin

scaling of the skin on the hands and feet

sensitivity of the eye to light

severe sunburn

skin rash

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sores, welting, or blisters

tearing

tingling of the hands and feet

ulceration of the skin

unusual tiredness or weakness

unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back or bone pain

burning, itching, and pain in the hairy areas, or pus at the root of the hair

change in taste

cough

decreased appetite

decreased weight

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

dizziness

dry skin

hair loss or thinning of the hair

headache

lack or loss of strength

loss of taste

muscle stiffness

nausea

pain in the arms or legs

rash

sunburn

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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New PLR Articles Directory Kentucky

Thursday 26 July 2012

Zelboraf