ZELBORAF® (Vemurafenib)
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ZELBORAF®
(ZEL-bor-raf)
(וועמאָראַפעניב)
קימאָוטעראַפּי
ZELBORAF®
(ZEL-bor-raf)
(וועמאָראַפעניב)
קימאָוטעראַפּי
What is ZELBORAF (vemurafenib)?
ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma,
- That has spread to other parts of the body or cannot be removed by surgery,
- And that has a certain type of abnormal “BRAF” gene.
- ZELBORAF is not used to treat melanoma with a normal BRAF gene.
It is not known if ZELBORAF is safe and effective in children under 18 years of age.
What is the most important information I should know about ZELBORAF?
ZELBORAF can cause serious side effects. These serious side effects include:
-
Risk of cancers. ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of
cancer called non-cutaneous squamous cell carcinoma (SCC). Talk with your healthcare provider about your risk for
these cancers. - Check your skin and tell your healthcare provider right away about any skin changes including a:
- ניו בראָדעווקע
- הויט ווייטיקדיק אָדער רעדיש זעץ וואָס בלידז אָדער טוט נישט היילן
- טוישן אין גרייס אָדער קאָליר פון אַ בראָדעווקע
- Your healthcare provider should check your skin before you start taking ZELBORAF, and every 2 months while taking ZELBORAF, to look for any new skin cancers. Your healthcare provider may continue to check your skin for 6 months after you stop taking ZELBORAF.
- Allergic reactions can happen while taking ZELBORAF and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction:
- Rash or redness all over your body
- טראָובלע ברידינג אָדער סוואַלאָוינג
- געשווילעכץ פון די פּנים, ליפן אָדער צונג
- Throat tightness or hoarseness
- Feel faint
- א שנעלער הארץ קלאפ
-
Severe skin reactions. Stop taking ZELBORAF and call your healthcare provider right away if you get a skin rash
with any of the following symptoms because you may have a severe skin reaction:
- blisters on your skin
- בליסטערז אָדער געשווירן אין דיין מויל
- peeling of your skin
- היץ
-
redness or swelling of your face, hands, or soles
פון דיין פֿיס
-
Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular
heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking
ZELBORAF and during your treatment with ZELBORAF to check the electrical activity of your heart. - Liver injury. Your healthcare provider should do blood tests to check your liver function before you start taking ZELBORAF and during treatment. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment:
- Yellowing of your skin or the white part of your eyes
- Dark or brown (tea color) urine
- עקל אָדער וואַמאַטינג
- אָנווער פון אַפּעטיט
- Pain on the right side of your stomach
-
אויג פּראָבלעמס. Tell your healthcare provider right away if you get any of these symptoms during treatment with
ZELBORAF:
- Eye pain, swelling, or redness
- Blurred vision or other vision changes
-
Worsening side effects from radiation treatment. Tell your healthcare provider if you have had or are planning to
receive radiation therapy. - ניר שאָדן. Your healthcare provider should do blood tests to check your kidney function before you start taking ZELBORAF and during treatment
- The most common side effects of ZELBORAF include:
- שלאָס ווייטיק
- ויסשיט
- האָר אָנווער
- טירנאַס
- עקל
- Sunburn or sun sensitivity
- יטטשינג
- וואָרץ
How should I take ZELBORAF?
-
Take ZELBORAF exactly as your healthcare provider tells you. Do not change your dose or stop taking ZELBORAF
unless your healthcare provider tells you to. - Take ZELBORAF every 12 hours with or without a meal.
- Do not crush or chew ZELBORAF tablets
- Do not take an additional dose of ZELBORAF if you vomit after taking your scheduled dose. Take your next dose at your regular time.
- If you miss a dose of ZELBORAF, take it as soon as you remember. If it is within 4 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose.
- If you take too much ZELBORAF, call your healthcare provider or go the nearest hospital emergency room right away.
וויכטיק זיכערקייַט אינפֿאָרמאַציע
-
Avoid sunlight while you are taking ZELBORAF. ZELBORAF can make your skin sensitive to sunlight. You may burn
more easily and get severe sunburns. To help protect against sunburn, when you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs, Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher. - זאג דיין געזונטהייט שפּייַזער אויב איר האָט קיין זייַט ווירקונג אַז בייז אָדער וואָס טוט נישט גיין אַוועק.
פרעגן דיין געזונט זאָרגן שפּייַזער אויב איר טאָן ניט וויסן.
What should I tell my healthcare provider before taking ZELBORAF?
- דערציילן דיין געזונט זאָרגן שפּייַזער וועגן אַלע מעדאַקיישאַנז איר נעמען, אַרייַנגערעכנט רעצעפּט און מעדאַקיישאַנז, אָן-די-טאָמבאַנק, וויטאַמינס און ערבאַל ביילאגעס.
- Before you take ZELBORAF, tell your healthcare provider if you:
- האָבן קיין האַרץ פּראָבלעמס, אַרייַנגערעכנט אַ צושטאַנד גערופן לאַנג QT סינדראָום
- האָבן לעבער אָדער ניר פּראָבלעמס
- have had or are planning to receive radiation therapy
- האָבן שוין געזאָגט אַז איר האָבן נידעריק בלוט לעוועלס פון פּאַטאַסיאַם, קאַלסיום אָדער מאַגניזיאַם
- האָבן קיין אנדערע מעדיציניש באדינגונגען
- are pregnant or plan to become pregnant. ZELBORAF can harm your unborn baby.
-
Females who are able to become pregnant should use effective birth control during ZELBORAF treatment and
for 2 weeks after the final dose. - Talk to your healthcare provider about birth control methods that may be right for you.
-
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with
ZELBORAF.
-
Are breastfeeding or plan to breastfeed. It is not known if ZELBORAF passes into your breast milk. Do not
breastfeed during treatment with ZELBORAF and for 2 weeks after the final dose. Talk to your healthcare provider
about the best way to feed your baby during this time
פאַראַנען 24/7
Experiencing
סימאָטאָמס אַז
זארגן איר
General information about ZELBORAF
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZELBORAF for a condition for which it was not prescribed. Do not give ZELBORAF to other people, even if they have the same symptoms that you have. It may harm them
What are the ingredients in ZELBORAF?
אַקטיוו ינגרידיאַנט: וועמאָראַפעניב
ינאַקטיוו ינגרידיאַנט: טאַבלעט קאָר: hypromellose acetate succinate, croscarmellose sodium, colloidal silicon dioxide,
magnesium stearate, hydroxypropyl cellulose.
קאָוטינג: pinkish white: poly (vinyl alcohol), titanium dioxide, polyethylene glycol 3350, talc, and iron oxide red.
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