Since the FDA created the Priority Review Program, aimed at fast tracking the development of drugs used to treat serious conditions, new hepatitis C medications are being approved at a faster rate.
Recently, the FDA approved Mavyret, a new combination medication for hepatitis C.
What is Mavyret prescribed for?
Mavyret is a combination medication indicated for the treatment of all major genotypes for chronic hepatitis C.
Mavyret will be available as a combination tablet in the strength of 100mg/40mg, supplied in a 4-week (monthly) dose wallet. The recommended dose is 3 tablets once daily, for 8 weeks, with food. You may need to take Mavyret for longer than 8 weeks if you have been previously treated with other medications, or have mild liver disease.
What are the most common side effects associated with Mavyret?
The most common side effects include headache and fatigue. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
Is there anything unique about Mavyret?
Yes. Mavyret is the only 8-week treatment for patients with hepatitis C, without liver disease, who have not been treated before.
How much will Mavyret cost?
Abbvie has priced Mavyret at $13,200 per month, or $26,400 per treatment course, before discounts. Although this is still expensive, Macyret is priced significantly lower than other hepatitis C treatments. For instance, popular medications Epclusa, Sovaldi and Harvoni are priced at $74,760, $84,000, and $94,500 respectively.
There is good news, though! Abbie offers a co-pay assistance program for commercially insured patients. If you are eligible, you may pay as little as $5 per co-pay using their Abbvie HCV Co-Pay Card. Visit the website here, and call 1-877-628-9738 to learn more and find out if you are eligible.
Believe it or not, medications are recalled on a daily basis and due to numerous reasons. Medication recalls can range from minor to life-threatening incidents if not immediately and appropriately taken care of.
What are these drugs prescribed for?
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication.
A small number of cartons containing cyclobenzaprine 5 mg tablets may potentially be mislabeled as amantadine 100 mg capsules. The blister pack inside the carton is correctly labeled as cyclobenzaprine 5 mg, though.
Taking the wrong medication may potentially cause severe adverse effects like dangerous drug interactions, sudden worsening of your disease, allergic reaction or death.
Which products were recalled?
The recall will affect the following:
- Drug: Cyclobenzaprine 5 mg tablets (50 unit dose) and amantadine 100 mg capsules (50 unit dose)
- Manufacturer: AvKare, Inc
- Packager: Apace Packaging, LLC
- National Drug Code (NDC)
What has Apace Packaging LLC done to alert those who may be affected?
Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product.
Distributors that have any of the product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for its return.
What do I do if I think I have a recalled package of Eliquis?
If you have questions regarding this recall you can contact Apace Packaging LLC by calling 270-434-2722 Monday-Friday from 8am–4pm Central Standard Time. You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using these drug products.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.
Menopause is the period in a woman’s life when menstruation stops. It typically occurs between 45 and 50 years of age and can increase the risk for medical conditions like heart disease, osteoporosis, urinary incontinence, weight gain, and painful intercourse.
The FDA has approved Intrarosa to treat dyspareunia (painful sexual intercourse), a common symptom of menopause, and it is now available in pharmacies.
What is Intrarosa indicated for?
Intrarosa is a steroid indicated for the treatment of moderate to severe dyspareunia, or painful sexual intercourse. This condition is a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is unique in that it treats dyspareunia without using hormones.
VVA is a chronic condition commonly associated with the loss of estrogen due to menopause. Symptoms of VVA include vaginal dryness, itchiness or burning.
Intrarosa is available as a vaginal insert in the strength of 6.5 mg.
How do I use Intrarosa?
Intrarosa is to be inserted vaginally once daily at bedtime.
What are the common side effects associated with Intrarosa?
Common side effects include vaginal discharge or noticeable changes on a Pap smear.
Are there any treatments similar to Intrarosa?
Over the counter (OTC) medication DHEA (prasterone) is an oral supplement that is sometimes used to treat dyspareunia. However, the FDA has not evaluated it for safety or efficacy.
OTC vaginal lubricants and moisturizers may also help to avoid discomfort during sexual activity, and can usually be found in the feminine care aisle of your grocery store or pharmacy.
Last month, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove their opioid pain medication Opana ER over concerns that the benefit of the medication may no longer outweigh its risks. You can read more about this request here.
Endo Pharmaceuticals has officially responded to the FDA’s request. On July 6th, 2017, Endo said that they would comply with the removal request of Opana ER, and would work with the FDA to ensure that this does not cause a problem for patients currently taking Opana ER. Despite this removal, Endo Pharmaceuticals still believe in the safety and efficacy of Opana ER.
What do I do if I am currently taking Opana ER?
If you are currently taking Opana ER, contact your doctor or healthcare provider to determine what your next step should be. You can work with your care provider to find another medication to help treat your chronic pain.
When will Opana ER no longer be available?
At this time, there has not been a determined date for Opana ER removal. Stay tuned, and GoodRx will keep you updated.
If you have type 2 diabetes, your doctor or health care provider has most likely prescribed you a long acting insulin like Lantus (insulin glargine), Toujeo (insulin glargine), or Basaglar (insulin glargine). These type of insulins work to control your blood sugar between meals and when you’re sleeping. They can be injected once or twice a day to give you around-the-clock blood sugar control.
Lusduna Nexvue (insulin glargine) is the newest brand of long-acting insulin to gain FDA approval.
What are insulin glargine products prescribed for?
Insulin glargine products are indicated to improve blood sugar control in adults and pediatric patients with type 1 diabetes, and adults with type 2 diabetes.
No. These insulin glargine products are considered new drugs and must be approved by the doctor as a new prescription. Although Basaglar, Lusduna, and Lantus share the same active ingredient, insulin glargine, they cannot be automatically substituted for one another unless you have approval from your doctor.
When will Lusduna be available?
Unsure. At this time Merck, the manufacturer of Lusduna, is involved in a patent infringement lawsuit with Sanofi, the manufacturer of both Lantus and Toujeo. Even though Lusduna has met all required standards for FDA approval, Lusduna has been tentatively approved and will be available in markets when the lawsuit is completed. Unfortunately, this could delay Lusduna’s release for even up to 30 months. Stay tuned, GoodRx will keep you updated!
For more information, read the press release from Merck here.