There is now another option available for the treatment of ulcerative colitis! The FDA has approved Simponi (golimumab) for adults with moderate to severe ulcerative colitis. Here is what you need to know:
What is ulcerative colitis?
Ulcerative colitis (UC) is a type of chronic inflammatory bowel disease (IBD) that affects the gut. It is immune-mediated and leads to chronic inflammation and ulcers in the lining of the intestines. Symtoms can include severe diarrhea, abdominal pain and bloody stools.
The Crohn’s & Colitis Foundation of America (CCFA) estimate that UC affects up to 700,000 people in the United States. UC is a chronic disease with no known cure, and requires chronic management of symptoms.
What is Simponi?
Simponi is part of a group of medicines known as TNF-blockers. Tumor necrosis factor (TNF) plays a role in causing the abnormal inflammatory and immune response of ulcerative colitis, and Simponi helps block the effect of TNF.
Simponi has previously been approved for other conditions including rheumatoid arthritis and psoriatic arthritis. You should only use Simponi for UC if you have become steroid-dependent, or if other treatment options available have failed, including corticosteroids, mercaptopurine, and azathioprine.
Is there anything else I need to know?
Simponi is available as a single-use injection, containing either 50 mg or 100 mg. Before self-administering, make you sure you go over the technique with either your provider or pharmacist, and read through the instructions. After starting therapy, Simponi is administered once a month.
Due to the way Simponi works you could be at an increased risk of developing infections, most commonly upper respiratory infections and fungal infections. Other potential side effects include injection-site reactions and swelling, shortness of breath, heart failure and neurologic problems.
You should not use Simponi if you have an active infection, a weak immune system, or diabetes.Additionally, you should be tested for Hepatitis B and tuberculosis before starting treatment.
If you have any questions, speak to your provider or pharmacist.
Till next week,
The GoodRx Pharmacist
You should wonder if a medication you often take for pain is safe. There are some misconceptions about NSAIDS (ibuprofen, naproxen, Motrin, Advil) and some truths. How much can or should you take and is it bad for your liver or kidneys? Every week I’m asked this question.
For the treatment of mild to moderate pain, minor fever, and acute or chronic inflammatory conditions 200 mg to 400 mg of ibuprofen will work, and is comparable to 650 mg of acetaminophen (Tylenol) or aspirin. Generally taken every 6 to 8 hours, the maximum dose of NSAIDs per day is 2400 mg which is 12 over-the-counter tablets.
Ibuprofen and other NSAIDS rarely affect the liver. Unlike acetaminophen (Tylenol) most NSAIDs are absorbed completely and have negligible first-pass hepatic (liver) metabolism. In other words, the way NSAIDS are metabolized makes liver toxicity (hepatotoxicity) very rare. Estimates are that 1 in 100,000 NSAID prescriptions result in acute liver injury. Generally NSAIDs are very liver-safe.
It’s about the kidneys:
NSAIDs have important adverse effects on the kidney that you should know about.
Here is the science behind the problem. Ibuprofen and other NSAIDs inhibit prostaglandins, and that can cause a problem because prostaglandins dilate blood vessels leading to the kidneys. Inhibiting prostaglandins may lead to kidney ischemia (dead tissue from decreased blood flow) and thus acute kidney injury.
A simple blood test may show a rise in creatinine if your kidneys are being affected, usually seen within the first three to seven days of NSAID therapy. Acute kidney injury can occur with any NSAID though naproxen seems to be a bigger culprit. In one study, folks who took NSAIDs had twice the risk of acute kidney injury within 30 days of starting to take the NSAIDs. Good news is it’s reversible if you stop taking them.
In people with high blood pressure, taking NSAIDs long term may worsen underlying high blood pressure. People with kidney problems at baseline more often get in trouble with NSAIDs, but if you are taking ibuprofen for long periods of time it’s not a bad idea to have a check of your kidney function with a quick blood test. Remember, acute kidney injury from NSAIDs doesn’t cause any symptoms.
Sum it up:
NSAIDs are safe for the liver, but can cause a problem with kidney function that is reversible if you stop taking them. Generally safe but worth paying attention to.
The oral tablets can cause liver and adrenal gland damage, and can have harmful interactions with other medications, prompting the FDA to approve a labeling change and to update the recommendations for use.
Talk to your doctor or pharmacist if you have any questions or concerns about Nizoral tablets, and you can find more information in the FDA Safety Alert here.
Invokana (canaglifozin) is now readily available at most pharmacies after receiving approval for the treatment of type 2 diabetes earlier this year. Here’s what you need to know.
What is Invokana?
Type 2 diabetes leads to elevated levels of glucose in the blood, because of the inability of your body either to make enough insulin or because your cells cannot use it properly. Invokana is a novel drug that works by blocking glucose from being reabsorbed by the kidney. This leads to more glucose being excreted from the body through urine, leading to lower blood glucose levels.
Invokana is the first of a class of medicines known as the SGLT2 (sodium glucose co-transporter 2) inhibitors.
Where does Invokana fit in your diabetes therapy?
Invokana is indicated, along with diet and exercise, to improve glycemic control if you have type 2 diabetes. It should not be used if you have type 1 diabetes or if you have severe kidney disease.
Initial studies showed that Invokana 100mg alone allowed people to achieve goal A1c levels (indicating average blood glucose levels) in 45% of patients versus 21% on placebo. With the higher dose, Invokana 300mg, this was seen in 62% of patients.
Invokana helps through an effect on weight loss as well. Obesity is a major contributing factor to insulin resistance, and weight loss of 5-8 pounds has been observed during studies.
Further studies showed improved glycemic control when adding Invokana to metformin, a first-line oral type 2 diabetes medication. Studies also showed Invokana lowered A1c levels more versus other oral diabetes medications, including Januvia (Invokana 300mg) and glimepiride (both Invokana 100mg and 300mg).
What should you know about your Invokana therapy?
In studies, the most common adverse effect observed was an increase in yeast infections, urinary tract infections and increased urination. The increase in yeast infections was seen more commonly in females and uncircumcised males.
Invokana can cause a lowering of blood pressure, which can lead to feeling faint. Your provider should also monitor blood potassium levels.
If you are taking any other medications, check for any possible interactions with either your provider or pharmacist.
Till next week,
The GoodRx Pharmacist
Concerns raised about ARBs (angiotensin receptor blockers) have folks worried. Patients have come to our offices asking if they should switch their blood pressure medication. Let’s shed some light on the issue as there is reason for calm. Well known ARBs include losartan (Cozaar), candesartan (Atacand), irbesartan (Avapro), Benicar (olmesartan), Diovan (valsartan) and Micardis (telmisartan). They work well to lower blood pressure and the kidneys of diabetics love them.
ARBs have been plagued with cancer fears since 2010 when the FDA reported that a review showed an increase in risk of cancer in patients taking an ARB compared to those not taking an ARB. Then in June 2011, the FDA released a statement concluding the evidence did not demonstrate that ARBs increase a patient’s risk of developing cancer. Yep there was reason to wonder what was going on.
After the older studies raised the possibility that ARBs might raise cancer risk, several other studies were done, and those were reassuring.
Two huge meta-analyses showed no increased risk of new cancer occurrence or cancer-related death with the use of ARBs in patients with hypertension, or heart failure. Take home message is this: overall, the bulk of evidence today indicates that ARBs are not associated with increased cancer risk.