Nasal polyps are common in people with allergies and asthma. Treatment has included nasal sprays and oral medications, and now we have a new one to add to the list, Xhance (fluticasone propionate).
What is Xhance indicated for?
Xhance is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older. It will be available as a nasal spray in the strength of 93 mcg.
The recommended dose of Xhance is one or two sprays per nostril twice daily. The Xhance delivery system is called the Optinose delivery system. It works to help deliver Xhance deep into the nasal cavity. Be sure to read the instructions before using the delivery system.
Who is at risk for nasal polyps?
Any condition that causes chronic inflammation in the nasal passages or sinus area may increase your risk of developing nasal polyps. The following conditions can put you at a higher risk for nasal polyps: asthma, aspirin sensitivity, allergic fungal sinusitis, cystic fibrosis and Churg-Strauss syndrome.
What are the common side effects associated with Xhance?
Common side effects include nosebleeds, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. Be sure to speak with your doctor if you experience any of these symptoms for a prolonged period of time.
- The strength of Xhance is 93 mcg per spray whereas the strength of Flonase is 50 mcg per spray.
- Xhance is indicated for the treatment of nasal polyps whereas Flonase is indicated for the management of allergy symptoms.
- Xhance requires a prescription whereas Flonase can now be purchased over-the-counter without a doctor’s prescription.
- Flonase is available in a generic version, as fluticasone propionate, whereas Xhance is only available as a brand name medication.
On September 21st, the FDA issued a drug safety communication for Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC).
The FDA warns that using Ocaliva can cause serious liver injury and even death when improperly dosed. The FDA has reviewed the 19 cases of death potentially caused by Ocaliva, and determined that in several cases patients with moderate to severe liver disease were receiving too high of a dose. This can result in an increased risk of serious liver injury or death.
What is Ocaliva indicated for?
Ocaliva is indicated in adults for the treatment of primary biliary cholangitis (PBC) with or without ursodeoxycholic acid.
Primary biliary cholangitis (PBC) is a rare liver disease in which your body begins to attack itself and destroy the bile ducts in the liver, leading to liver damage or eventual cirrhosis.
What are the signs and symptoms of associated with liver function?
If you or someone you know is taking Ocaliva, be sure to seek medical attention for the following signs and symptoms:
- New or worsening tiredness
- Weight loss
- Stomach pain
- Decreased appetite
- Nausea and vomiting
- change in behavior or confusion
- Anxiety or unease
- Stomach swelling
- Yellowing of the eyes or skin
- Bloody stool
What is being done to warn people about these serious side effects?
The FDA is reminding healthcare providers to determine patients’ baseline liver function before starting a patient on Ocaliva.
What does the FDA recommend prescribers do?
The FDA recommends the following:
- Patients with moderate to severe liver impairment should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dose.
- Healthcare professionals should monitor patients frequently for disease progression, and reduce the dosing frequency for patients who progress to moderate or severe liver impairment.
- All patients treated with Ocaliva should be monitored frequently for liver injury (e.g. worsened liver blood tests and adverse liver-related reactions).
- If liver injury is suspected, discontinue Ocaliva.
- After the patient has stabilized, weigh the benefits against the risks when deciding whether to re-initiate treatment. Educate patients about the symptoms of potential liver injury.
Gout is a form of arthritis that affects the joints and can cause severe pain, redness, tenderness, and inflammation. Typically, gout is caused by a build-up of uric acid.
Recently, the FDA approved Duzallo, a new combination medication for the treatment of gout.
What is Duzallo indicated for?
Duzallo is a combination medication indicated for the treatment of hyperuricemia associated with gout. It is specifically for patients who have not achieved target serum uric acid levels allopurinol alone.
Duzallo combines tw0 gout medications, Zurampic (lesinurad) and Zyloprim (allopurinol), into a convenient once-daily regimen. Duzallo is the 1st FDA approved fixed-dose combination treatment for patients with gout that addresses both the increased production of uric acid as well as the decreased elimination of uric acid.
Who is at risk for gout?
The following conditions may put you at risk for gout: led exposure, high blood pressure, kidney problems, hypothyroidism, psoriasis, cancer, Kelly Seegmiller syndrome, and Lesch-Nyhan syndrome.
How is Duzallo to be taken?
The recommended dose of Duzallo is one tablet once daily. It is available as a combination tablet in the strength of 200 mg/200 mg and 200 mg/300 mg Be sure to stay hydrated while taking this medication.
What are the common side effects associated with Duzallo?
The most common side effects associated with Duzallo include headache, influenza, higher levels of blood creatinine, and heartburn.
When will Duzallo be available?
Proper disposal of sharp medical objects—like syringes, needles, or lancets—is important to prevent injury. The improper disposal of needles or sharps is dangerous and can increase the risk for a needle stick injury, which can spread blood-borne diseases like HIV or various forms of hepatitis.
Many states have laws regarding sharp disposal, so it’s important to understand proper disposal practices.
What are examples of sharps that require proper disposal?
Examples of types of medications that will require proper disposal include the following:
- Vitamin B-12 injections
- Testosterone injections
- Insulin injections like Humalog, Lantus or Toujeo
- Blood thinner injections like Lovenox (enoxaparin)
- Epinephrine injections like Epipen or Adrenaclick
- Migraine injections like Imitrex (sumatriptan)
How should I dispose of my sharps?
- Check for free options. Contact the manufacturer of your drug, or your health department to see if they have a free mail-back program, or free sharps containers. Trulicity, for instance, gives away free sharps containers on their website.
- Find a drop-off location. Hospitals, doctors offices, and health clinics are a good place to start. Oftentimes they have a sharps disposal drop-off box, but be sure to call first. You can also contact your state’s department of public health to find a drop-off location close to you.
What type of container can I use to dispose of my sharps?
You can use one of the following types of containers to dispose of your sharps or needle-containing products in your household:
- FDA-cleared sharps container
- Empty laundry detergent container
- Empty bleach container
- Empty Drano container
If you use an empty household container, be sure that you are following FDA guidelines. Proper sharps containers should be able to be properly closed and stand on its own, leak resistant, made of heavy-duty plastic, and should be properly labeled to warn of hazardous waste.
You can purchase an FDA-cleared sharps container without a prescription or you can ask your doctor to write a prescription for you so that your local pharmacy can try to bill your insurance to see if it’s covered.
Does each state have their own guidelines regarding sharps disposal?
Yes. If you have questions or would like more information specific to your state call Safe Needle Disposal at 1-800-643-1643 or e-mail at firstname.lastname@example.org.
What is a biosimilar?
Without getting too technical, biosimilars are basically the generic product of a biologic (a medication made from a living organism). However, because these medications are made out of living cells they are slightly different. The good news about biosimilars is that they are typically 15%-30% less expensive than their reference drug.
For more information about biologics and biosimilars, read our blog here.
What is Cyltezo indicated for?
Cyltezo is approved for the following 7 conditions:
- Pediatric patients 4 years of age and older with moderate to severe active polyarticular juvenile idiopathic arthritis
- Moderate to severe active rheumatoid arthritis
- Moderate to severe active adult Crohn’s disease
- Moderate to severe active ulcerative colitis
- Moderate to severe plaque psoriasis
- Active ankylosing spondylitis (arthritis of the spine)
- Active psoriatic arthritis
Keep in mind that Cyltezo is only approved for 7 indications whereas Humira has 10 indications. These three indications that Humira also treats include uveitis, hidradenitis suppurativa, and pediatric Crohn’s disease.
How will Cyltezo be sold?
Cyltezo will be available in a single-use prefilled glass syringe in the dosage of 40 mg/0.8 ml. The manufacturer, Boehringer Ingelheim, will also seek approval for an auto-injector in the future.
What are the most common side effects of Cyltezo?
The most common side effects include infections, injection site reactions, headache or rash.
Although these two are both biosimilars for Humira, they are different. Amjevita will be available additionally in a single-use prefilled glass syringe in the 20 mg/0.4 mL strength as well as a SureClick autoinjector in the 40 mg/0.8 mL strength.
Is Amjevita currently available?
How much will Cyltezo cost?
No. Although Cyltezo is a biosimilar, it is not interchangeable.
Interchangeable products are usually known as generic medications and can be substituted for a brand name medication if available and without needing to consult the prescriber. Your doctor must write your prescription for Cyltezo if this is the medication that is intended for you to use.