What is this Saxenda? It’s a higher dose of Victoza, which has been available in the US since 2010 for the treatment of type 2 diabetes. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. The dose for obesity is 3.0 mg (Saxenda), in contrast to 1.2 mg or 1.8 mg for diabetes (Victoza).
Ok, give me the warnings: The product will have a boxed warning stating that thyroid C-cell tumors have been seen in rodents, but the risk in humans is unknown. The most common adverse event in people taking Saxenda was nausea and diarrhea, both of which got better over time.
Does Saxenda work? In the largest trial involving 3731 patients, the Saxenda group lost an average 8% of body weight vs 2.6% with placebo at 56 weeks. So, that’s a 16 pound weight loss if you are 200 pounds. One comforting thing is that Saxenda is a higher dose of a drug that’s been around for a while (Victoza) so it’s not a total mystery.
You may be unfamiliar with the terms biologics or biosimilars but if you watch television you may have seen a commercial for them and not even know it! For example – the popular arthritis or Crohn’s medications Enbrel and Humira are biologics.
Biologics are medications that are typically expensive and usually obtained from a specialty pharmacy. Biologics are generally not used as first line treatment but instead considered by your doctor after other less expensive treatment options have been tried and failed.
Now that you have an idea of what a biologic is, understanding what a biosimilar is should be relatively easy.
This analogy may help: Brand is to generic as biologic is to biosimilar . . . sort of.
Without getting too technical, biosimilars are basically the generic product of a biologic. However, because these medications are made out of living cells they will be slightly different.
What might you find a biologic or biosimilar made for?
Here are some examples of conditions or disease states that biologics or biosimilars may be made to treat:
- Autoimmune diseases like multiple sclerosis (MS)
- Inflammatory diseases like Crohn’s disease or ulcerative colitis
- Pulmonary arterial hypertension
- Hepatitis B and C
What are some examples of biologics that are currently available?
Would there be an advantage to using a biosimilar compared to a biologic?
One advantage would be cost. Biosimilars could present a huge cost savings for patients and insurance companies once they are approved.
Does the FDA have an approval process in place for biosimilars?
Yes. The FDA has created a process for biosimilar approval that can be found here, and starting in summer 2014, several pharmaceutical companies have filed applications for approval of their exclusive biosimilar products. Some of these biosimilars may be available as soon as 2015.
Want more information?
The FDA answers some frequently asked questions regarding biologics here.
The Gardasil vaccine is intended to give protection against diseases caused by Human Papillomavirus or HPV. Now, the Food and Drug Administration (FDA) has approved a new form of the vaccine, Gardasil 9. This new form of Gardasil protects against 9 strains of the HPV virus where the current formulation only protects against 4 strains.
What is HPV?
HPV or human papillomavirus is a virus that is transmitted from sexual contact with someone who has the virus. It is the most common sexually transmitted infection.
What strains of HPV does the current vaccine, Gardasil, cover?
The current vaccine, Gardasil, offers protection from the 4 strains of HPV: 6, 11, 16, and 18.
What strains of HPV will the new vaccine, Gardasil 9, cover?
How is the Gardasil 9 vaccine given?
You will start with one shot, followed by separate shots at two and six months later.
When will Gardasil 9 be available to patients?
How is the newly approved Gardasil 9 an improvement over the current Gardasil vaccine?
Gardasil 9 protects against 5 additional strains of HPV. Those 5 additional strains are considered the most common cervical cancer-causing types worldwide. Seven of the 9 HPV strains covered by Gardasil 9 cause approximately 90% of all cervical cancer cases.
In contrast, the original Gardasil only protected against strains responsible for about 70% of cervical cancer cases.
Want more information on Gardasil 9?
Yes, if you are over 65 you do. These recommendations changed in the United States in September 2014 and I would call them a sweeping change. Pneumococcal vaccines don’t protect you from ALL pneumonia but they do protect you from Strep pneumococcal infections including pneumonia and meningitis which remain an important source of illness and even death among older adults.
What’s new? For all adults ≥ 65 years of age, there are two recommend pneumococcal vaccinations (booster shots). Vaccination now consists of two vaccines: Pneumovax 13 (aka Prevnar 13) AND Pneumovax 23.
What were the old recommendations? Until September of this year if you are over 65 you received the 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23). Now you need TWO pneumonia vaccines. In September 2014, the United States Advisory Committee on Immunization Practices (ACIP) began also recommending the pneumococcal conjugate vaccine (Pneumovax 13/Prevnar) for all adults ≥ 65 years of age.
Do I get them at the same time? Current recommendations for individuals ≥ 65 years of age who have not previously received either vaccine are to get them as follows: first Pneumovax 13, followed 6 to 12 months later by Pneumovax 23. In patients who have already received Pneumovax 23, at least one year should elapse before they are given Prevnar (Pneumovax 13).
Why did we change this, do we really need more vaccines? The revision was prompted by results from a huge clinical trial. After looking at 85,000 adults ≥ 65 years of age in the Netherlands, it was found that Pneumovax 13 protected older folks against pneumococcal pneumonia.
Is there debate here? Yep, a little. Know this: infants here in the United States routinely get Prevnar (Pneumovax 13) and in the Netherlands they didn’t at the time of this study. So, some concern has been raised that since this trial began before pneumovax 13 was used routinely in infants in the Netherlands, it might not answer the question of whether its use in adults is efficacious in countries that routinely vaccinate infants . . . like ours.
The names (and active ingredients) of Renagel and Renvela are almost identical and can be extremely confusing. These medications both treat high phosphate levels, but they have varying insurance coverage, and can’t be substituted for one another without your prescriber’s approval.
Sevelamer hydrochloride and sevelamer carbonate are used to treat hyperphosphatemia, also known as high phosphate levels. High phosphate levels may be caused by the consumption of phosphate-rich foods (like dairy products), or the result of kidney failure.
Your kidneys help filter waste products in your body, and kidney failure is due to the build-up of waste products not properly being excreted. Some types of kidney failure can be reversed, though others are irreversible.
It is especially important to take care of yourself if you have a disease such as diabetes or high blood pressure which can potentially lead to kidney failure if not appropriately controlled. Keeping up with your sugar readings and keeping your blood pressure numbers under control can help prevent the progression of chronic kidney disease to kidney failure.
What dosage forms are sevelamer hydrochloride and sevelamer carbonate available in?
Sevelamer hydrochloride (Renagel) is available as a tablet, in both 400 mg and 800 mg strengths.
What is are the advantages and disadvantages of using sevelamer hydrochloride (Renagel)?
Sevelamer hydrochloride is a calcium-free, metal-free, nonabsorbed phosphate binder that has proven effective in controlling serum phosphorous levels in patients with chronic kidney disease.
However, some patients cannot tolerate it due to stomach side effects.
What are advantages and disadvantages of using sevelamer carbonate (Renvela)?
Sevelamer carbonate offers the same exact advantages as sevelamer hydrochloride, with the additional benefit of a carbonate acid buffer.
Sevelamer carbonate is also available in powder packets for oral suspension. The powder packets are sprinkled into a prescribed amount of water depending on the strength. The powder packets are a great advantage for those patients who have a hard time swallowing tablets or capsules.
Sevelamer carbonate might help reduce the risk of acidosis (too much acid in the bodily fluids), but also has the potential for stomach side effects.
The 800 mg tablet is also available as an authorized generic, which may be less expensive and/or more likely to be covered by your insurance.
Which medication will my insurance cover?
Unfortunately each prescription insurance plan differs so it’s hard to make a blanket statement about which medication is most likely to be covered by your individual plan.
More than likely only Renagel or Renvela will be covered by your insurance since the cost is similar and sevelamer hydrochloride and sevelamer carbonate are almost identical in efficacy. The main differences are a result of their side effect profiles.