Complicated multi-pill regimens are treatments of the past for many chronic health issues, and HIV is no exception. Pharmaceutical companies are realizing that more is not better and are developing less complex treatments to increase patient adherence.
On November 21st the FDA approved Juluca, the first two-drug regimen for certain patients with HIV, and it is now available in pharmacies.
What Juluca indicated for?
Juluca is a two-drug combination medication indicated as a complete regimen for the treatment of HIV-1 infection in adults. It is intended to replace the current antiretroviral regimen for those who are virologically suppressed for at least six months with no history of treatment failure.
Is there anything unique about Juluca?
Yes. Juluca is the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.
Are there any side effects associated with Juluca?
The most common side effects include diarrhea and headache. More serious side effects include skin rash, allergic reactions, liver problems, depression, and mood changes.
For more information on Juluca, see the press release from Viiv Healthcare.
Is metformin (Glucophage) bad for you? There is quite a bit of misinformation out there about this commonly used medication. Metformin therapy may cause diarrhea and lower vitamin B12 levels, but most things you hear about metformin aren’t true.
Here are some common metformin myths.
- Metformin is bad for your kidneys. It’s not. What may be confusing folks here is that until 2016 patients with a creatinine level above 1.5 were advised not to take metformin. Metformin does not cause the kidney problems and in fact, 2016 labeling on Metformin was changed to indicate it should not be used only in those with late-stage chronic kidney disease stage IV or V.
- Metformin is bad for your liver. Truth is, it’s not. Metformin isn’t metabolized at all by the liver and instead is excreted unchanged in the urine. Metformin-induced liver injury is a rare, but possible adverse drug reaction that usually occurs at 4-8 weeks of therapy.
- Metformin is dangerous to take if you want to become pregnant. This is not true, and in fact may be the opposite. Metformin therapy during pregnancy in women with PCOS is associated with a reduction in miscarriage rate and gestational diabetes and did not adversely affect birth weight or development at 3 and 6 months of life.
- Metformin causes dementia. No. In fact a recent study of 17,000 diabetic vets found that taking metformin was associated with a lower risk of dementia than sulfonylureas like glyburide or glipizide. Other studies have shown metformin use to be associated with reduced rates of dementia and improved cognitive function.
- Metformin is bad for your heart. This is one I hear quite a bit from patients and it’s not true. Metformin has been suggested to exhibit cardioprotective effects in the setting of a heart attack. Metformin therapy is also associated with lower rates of death in patients affected by both diabetes and heart failure and reduced risk of cardiac failure morbidity and mortality in diabetic patients.
- Metformin causes cancer. This is also not true and metformin appears to have a protective effect. In just one example the Women’s Health Initiative (WHI) found that metformin was associated with less cancer-related mortality in patients with diabetes. Metformin has also been shown to reduce recurrence of colorectal polyps suggesting a protective role in colon cancer.
- Metformin causes scary lactic acidosis. The risk of metformin causing acidosis of the blood is exceedingly rare. A Cochrane systematic review of 70,490 type 2 diabetics on metformin did not report a single case of metformin lactic acidosis. The risk of metformin causing lactic acidosis appears to be no greater than with non-metformin therapies.
- Metformin is bad for the pancreas. Metformin is not a known cause of acute pancreatitis and lowers, not raises, the risk of pancreatic cancer.
- You can’t have a CT scan with contrast if taking metformin. Intravenous contrast is often given prior to CT scan imaging. In patients with no evidence of acute kidney injury and without end-stage kidney disease there is no risk and no need to discontinue metformin either prior to or following the administration of contrast media. In patients taking metformin who are known to have acute kidney injury or severe chronic kidney disease (stage IV or stage V) metformin should be temporarily discontinued at the time of or prior to the procedure, and withheld for 48 hours subsequent to the procedure.
- Metformin raises cholesterol. Nope! In fact, metformin has a beneficial impact on lipid (cholesterol) metabolism and lowers LDL cholesterol along with lowering triglycerides.
Not all injectable diabetes medications contain insulin. A newer class of medications used for people with type 2 diabetes are considered non-insulin injectables and include drugs like Byetta, Victoza, Bydureon, and Trulicity.
Recently the FDA approved, Ozempic, a new non-insulin injectable for people with type 2 diabetes.
What is Ozempic indicated for?
Ozempic is a medication to be used in addition to a healthy diet and exercise to improve blood sugar control in adults with type 2 diabetes.
How is Ozempic to be used?
Ozempic will be available as a pre-filled, disposable, single-patient-use pen injector to be injected into the stomach, thigh, or upper arm. Your doctor will determine your specific dose of Ozempic as it may vary from person-to-person. The starting dose of Ozempic is 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly.
If after at least 4 weeks additional blood sugar control is needed, increase to a maximum dose of 1 mg once weekly.
Are there any other supplies I will need for injecting Ozempic?
Yes. You will need the following supplies for injecting Ozempic:
- Sharps container to be used for safe disposal of the used pen needles. You can use a hard plastic container like an empty bleach jug or laundry detergent container. You can also use an FDA-cleared sharps container.
- Alcohol swabs to wipe the area of skin where you will be injecting Ozempic
What are the common side effects associated with Ozempic?
Common side effects include nausea, vomiting, diarrhea, stomach pain, and constipation.
Ozempic also has a black boxed warning, the strongest warning given by the FDA, for the possibility of causing thyroid tumors.
Is there anything unique about Ozempic?
Yes. The main ingredient of Ozempic, semaglutide, is currently undergoing 2 global clinical trials for an oral formulation that can be taken by mouth rather than injected. If it proves to be successful, semaglutide would be the first oral formulation in this class of medications.
One of the only ways to treat diabetes type 1 and 2 are through insulin injections, like Lantus (insulin glargine), that help to control blood sugar. Unfortunately, doctors consistently report low levels of adherence to insulins, Lantus included. The main reason? The cost.
Lantus is a prime example of an expensive insulin—averaging around $274 per month, it is unaffordable for many. But GoodRx is here to help.
Here is some information on Lantus, and how you can save
Why are insulins, and Lantus, so expensive?
The case of insulin prices is an interesting one. In the 1920s, insulin was extracted from cattle pancreas, which led to negative reactions in some patients. So, scientists made it better. In the 1970’s a new type of insulin was developed using a technique called recombinant DNA technology. This technique uses human DNA to create the insulin needed and ultimately reduced complications.
But the catch? After the new insulin with human DNA was created, the older and more affordable insulin was taken off the market in the US. Since then, the demand for diabetes medications has increased, and the cost of insulin has skyrocketed, leaving many paying an anywhere from $300-$900 per month for their life-saving injection.
How popular is Lantus?
Lantus is currently the most popular insulin, a class of medications that are used to lower blood sugar and treat diabetes type 1 and 2.
Lantus was developed by Sanofi in 2000, and for many years was one of Sanofi’s top-grossing drugs. However, in recent years, with the development of other insulins, Sanofi has seen a decline in Lantus sales. While we haven’t seen the effects of this decline quite yet, it could mean that Sanofi will need to reduce the price for Lantus to stay competitive. Stay tuned.
Does Lantus have a generic?
Although Sanofi’s patent on Lantus expired in 2015, as of December 2017, Lantus still does not have a generic equivalent. But there is good news—Lantus does have a biosimilar, Basaglar.
What’s a biosimilar you ask? Well, without getting too technical, biosimilars are basically the generic product of a biologic. But since these medications are made out of living cells, they are slightly different and aren’t deemed therapeutically equivalent, or interchangeable, by the FDA. For more information about biosimilars, see our previous blog post here.
Lantus or Basaglar?
Basaglar is a biosimilar to Lantus and has the same active ingredient—insulin glargine. But is there a difference between the two?
In short, not really. Like Lantus, Basaglar is a long-acting insulin that generally lasts for about 24 hours. The only big difference is the price, as Basaglar is about 15% less expensive than Lantus.
Are there any other alternatives to Lantus?
There are a couple of other options to Lantus or its biosimilar Basaglar. While the cash prices of these may not significantly less expensive, depending on your insurance coverage, some alternative insulins might be more affordable.
- Toujeo is another insulin glargine injection and has been found to be just as safe and effective as Lantus. The difference? Toujeo is more concentrated at 300 units/ml (versus 100 units/ml for Lantus) and is only approved to treat patients 18 years or older. However, Toujeo is more expensive than Lantus as cash prices average around $347 for a 30-day supply.
- Levemir has a different active ingredient than Lantus, insulin detemir, but is similar in that is provides all-day blood sugar control. Levemir is actually more expensive than Lantus, as cash prices average around $497, but if your insurance covers it over Lantus, it may be more affordable for you.
Lantus still works best for me, how can I save?
- Save with a manufacturer coupon or patient assistance program. Sanofi offers a manufacturer coupon program and patient assistance program for patients with and without insurance coverage. The Sanofi Rx Savings Card can reduce your out-of-pocket cost to as little as $0 per month, while Sanofi Patient Connection can help you receive your medication at no cost if you qualify. Check our Lantus savings tips page for more information on these programs.
- Use a GoodRx Lantus coupon. GoodRx offers discounts for Lantus online, which can usually save at least 15% off the full retail price. GoodRx has also partnered with pharmacy benefit manager Express Scrips to lower the cost of select brand-name drugs by up to 50%. This program, called Inside Rx, can reduce your out of pocket cost for Lantus to around $275 with a coupon. Read our post here for more information on Inside Rx.
- Try to appeal your coverage. If you have insurance and your plan doesn’t cover Lantus, ask your doctor about submitting an appeal, Some plans require prior authorizations—meaning you need permission from your insurance plan and a special request from your doctor before you can fill your prescription. If you have insurance, call your provider and ask how to get this process started.
A new safety alert was issued on November 11th for Limbrel, a medical food for patients with osteoarthritis.
What is Limbrel indicated for?
According to the manufacturer, Limbrel is the first prescription product developed and formulated specifically to safely meet the distinctive nutritional requirements of patients with osteoarthritis.
Limbrel is only available with a prescription, as FDA regulations require that it be used only under a physician’s supervision.
Why was a safety communication issued for Limbrel?
The FDA issued a safety communication for Limbrel as they received a range of adverse events reported to them. In early September, the manufacturer began investigating a rise in reports of serious adverse events.
In total, the FDA has received 194 adverse event reports regarding Limbrel including the following 2 serious and potentially life-threatening medical conditions among them:
- Drug-induced liver injury
- Hypersensitivity pneumonitis
Has Primus Pharmaceuticals responded to the FDA’s request?
On December 8, 2017, the manufacturer of Limbrel posted a statement on Limbrel safety and FDA review to their website.
Primus Pharmaceuticals still has not voluntarily recalled Limbrel as they state they are waiting to obtain the documents on which the FDA has based its safety alert and recall request prior to making a final decision.
Primus Pharmaceuticals feels as though there is conflicting information from the FDA on the adverse effects of Limbrel based on the opinions of independent experts and medical literature in regards to their product; however, they would like to collaborate with the FDA to assure the best solution for both patients and prescribers.
What should I do if I am currently taking Limbrel?
If you are currently taking Limbrel the FDA recommends you do the following:
- Immediately stop taking it and contact your healthcare provider
- If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your healthcare provider to report your symptoms to the FDA through MedWatch