CDC Vaccination Recommendations for Pregnant Women
The Centers for Disease Control and Prevention (CDC) has released information about the importance of pregnant women receiving flu and whooping cough vaccinations.
Click here for more information.
Withdrawn: Zinbryta for Multiple Sclerosis
After reports of brain swelling (encephalitis and meningoencephalitis), the makers of Zinbryta® (daclizumab) have decided to withdraw it from the market.1
If you are taking Zinbryta, please call your program nurse.
Zinbryta was approved by the FDA (US Food and Drug Administration) in 2016 as an option for adults with relapsing multiple sclerosis. The drug carried a boxed warning about the risks of liver damage.
Zinbryta can still be used while its makers, Biogen Inc. and AbbVie, are working with the FDA on a withdrawal date. If you are taking Zinbryta, work with your doctor to explore other treatment options. CVS Health is also reaching out to doctors who have patients taking Zinbryta.
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- Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorizations for Zinbryta® (daclizumab) for relapsing multiple sclerosis. BusinessWire website. 苹果手机上推特教程. Accessed March 2, 2018.
FDA Issues Warning on Risk of Anaphylaxis with Varubi® (Rolapitant)
The FDA (US Food and Drug Association) has sent out a warning for people who use Varubi (rolapitant) to treat CINV (chemotherapy-induced nausea and vomiting). Varubi may cause a severe allergic reaction. Look for signs of:
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- Swelling of the face or throat
- Hives or redness on skin
- Itching
- Abdomen cramping or pain
- Throwing up
- Back or chest pain
- Low blood pressure
- Shock (cold skin, rapid pulse, dizzy, etc.)
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Varubi is used in adults who are on chemotherapy and using other drugs to control CINV. Doctors and patients should watch for signs of a reaction during and after giving Varubi. Check for allergies to Varubi's ingredients, like soybean oil or legumes. Do not give Varubi to patients who may have a reaction. Allergic reactions can be treated.
If the patient has an allergic reaction:
- Stop Varubi infusion
- Treat the reaction (epinephrine or other antihistamine)
- Do not use Varubi again
How to report side effects:
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- Submit a report online at: www.fda.gov/MedWatch/report
- Download the report form or call 1-800-332-1088 to request one by mail. Fill out and return to the address on the form. Or, fax it to 1-800-332-0178.
Reference
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions. www.fda.gov. January 16, 2018. Accessed January 16, 2018.
FDA Approves Hydroxyurea for Treatment of Sickle Cell Disease in Children
The FDA (US Food and Drug Administration) approved hydroxyurea (Siklos®) for use in children with SCD (sickle cell disease) on December 21, 2017. Hydroxyurea can help lower the number of pain crises and blood transfusions in children ages 2 and older.1
Taking Hydroxyurea (Siklos):
This drug comes in 100 mg and 1,000 mg tablets. The dose is based on the child's weight and blood counts.2 The tablet is taken once a day with a glass of water or small amount of food. For children who can't swallow the tablets, mix the tablet in a small amount of water in a teaspoon.
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References
- Sickle cell anemia drug gains FDA approval. Specialty Pharmacy Times website. December 21, 2017. www.specialtypharmacytimes.com. Accessed December 21, 2017.
- Siklos [package insert]. Medunik USA; December 2017.
- FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemia. Prescribing Guide. www.fda.gov. Accessed January 11, 2018.
FDA Approves Soliris® (eculizumab) for Myasthenia Gravis
The FDA (US Federal Drug Administration) has approved Soliris for adults who have generalized myasthenia gravis. Soliris is only used with patients who have not been able to control symptoms with standard therapy. This drug is used to slow or stop the immune system from making muscles weak.1
Soliris is offered through a limited program. Only your doctor can enroll you in this program.
Risk for Infection
If you take Soliris, your doctor will watch you for a certain type of infection called meningococcal
(muh-ning-go-ka-kul) disease. This is sometimes called meningitis (men-nin-ji-tis). Meningitis needs early treatment so it isn't fatal. If you have any signs of infection, call your doctor right away. Look for2:
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- Stiff neck
- Headache
- Nausea or vomiting
- Bothered by bright light
- Confusion
Your doctor may need to give you a meningococcal vaccine at least two weeks before you start treatment. But, your doctor may decide that you need to start taking Soliris sooner.3 Talk with your doctor about when you can start treatment.
Using Soliris
Soliris is a weekly IV infusion. Your dose will increase slowly over a few weeks. Tell your doctor right away if you have any bone or muscle pain.
References
- FDA approves Soliris® (eculizumab) for the treatment of patients with generalized myasthenia gravis (gMG). Press release. Alexion website. October 23, 2017. http://www.alexion.com/. Accessed October 30, 2017.
- Meningococcal Disease: Signs and Symptoms. Centers for Disease Control and Prevention. http://www.cdc.gov/meningococcal/about/symptoms.html. Accessed November 3, 2017.
- Soliris [package insert]. New Haven, CT: Alexion Pharmaceuticals, Inc.; October 2017.
