| Xolair 150MG Solution for Reconstitution | GENENTECH | 1/$658.74 or 3/$1976.21 |
Special Alerts:
[UPDATE 07/02/2007] Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for omalizumab (Xolair) was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for omalizumab is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, omalizumab should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each omalizumab injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair , http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm, http://www.fda.gov/cder/foi/label/2007/103976s5102lbl.pdf and http://www.fda.gov/cder/foi/label/2007/103976s5102mg.pdf.
[Posted 02/21/2007] FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with omalizumab (Xolair). Usually these reactions occur within two hours of receiving a omalizumab subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis—with onset two to 24 hours or even longer—after receiving omalizumab treatment. Anaphylaxis may occur after any dose of omalizumab (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer omalizumab should be prepared to manage life-threatening anaphylaxis and should observe their omalizumab-treated patients for at least two hours after omalizumab is given. Patients under treatment with omalizumab should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following omalizumab treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the omalizumab label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair, http://www.fda.gov/cder/drug/infopage/omalizumab/default.htm and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01567.html.
What is omalizumab?
Omalizumab is an antibody that helps decrease allergic responses in the body. Omalizumab is used to treat moderate to severe asthma that is caused by allergies. Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms. Omalizumab may also be used for purposes other than those listed in this medication guide.
What is the price of this medication and similar alternatives?
This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
| Xolair 150MG Solution for Reconstitution | GENENTECH | 1/$658.74 or 3/$1976.21 |
What are the possible side effects of omalizumab?
Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.
Get emergency medical help if you have any of these
wheezing, tightness in your chest, trouble breathing;
hives or skin rash;
feeling anxious or light-headed, fainting;
warmth or tingling under your skin; or
swelling of your face, lips, tongue, or throat.
Other serious side effects include easy bruising or bleeding, or unusual weakness.
Less serious side effects may be more likely to occur, such as:
pain;
tired feeling;
joint or muscle pain;
dizziness;
ear pain;
hair loss;
mild itching or skin rash;
sore throat or cold symptoms; or
redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.
This not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
How should I use omalizumab?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Omalizumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Omalizumab is usually given every 2 or 4 weeks. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
What is the most important information I should know about omalizumab?
Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer. Get emergency medical help if you have any of these
What happens if I miss a dose?
Contact your doctor if you miss a dose of omalizumab.
What other drugs will affect omalizumab?
There may be other drugs that can affect omalizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?
Omalizumab has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of maternal toxicity, embryotoxicity, or teratogenicity. There are no controlled data in human pregnancy. Omalizumab is only recommended for use during pregnancy when benefit outweighs risk.
There are no data on the excretion of omalizumab into human milk. Studies with cynomolgus monkeys have demonstrated milk levels that were 1.5% of maternal blood levels. IgG is excreted into human milk and it is expected that omalizumab is also excreted. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering omalizumab to nursing women.
Who should NOT use this medication?
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of omalizumab is not likely to produce life-threatening symptoms.
What should I discuss with my healthcare provider before using omalizumab?
Do not use this medication if you are allergic to omalizumab. Before using omalizumab, tell your doctor if you have any other medical conditions or if you take other medicines. Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.
I am on so many medications; do I have to take them all?
This is called polypharmacymany different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.
Where can I get more information?
More Information
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