5
1 Model is for illustrative purposes only. Welcome to Synthroid Precise Dosing Options Use 1 SYNTHROID ® (levothyroxine sodium) tablets, for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis). Safety Considerations 1 • Thyroid hormones, including SYNTHROID, should not be used for the treatment of obesity or weight loss. Large doses of thyroid hormone, especially when used with certain drugs that reduce appetite, can result in serious and even life-threatening effects. • Do not use SYNTHROID if you have uncorrected adrenal problems. • Excessive amounts of levothyroxine sodium therapy have been associated with decreased bone strength, especially in women after menopause. • Talk to your doctor about all medications you are taking, pregnancy plans, and all medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. Tell your doctor if you are taking SYNTHROID prior to any surgery. • Tell your doctor if you experience rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event. Look inside for important information to help you stay on track with Synthroid. 25 mcg orange 50 mcg white 75 mcg violet 88 mcg olive 100 mcg yellow 112 mcg rose 125 mcg brown 137 mcg turquoise 150 mcg blue 175 mcg lilac 200 mcg pink 300 mcg green Tablets shown not actual size and may not represent exact color. Please see additional Important Safety Information, including BOXED WARNING regarding inappropriate treatment for obesity or for weight loss, on page 5. Please click here to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

Welcome to Synthroid Precise Dosing Options Brochure.pdf · SYNTHROID® (levothyroxine sodium) ... or visit . The Food and Drug Administration has determined that certain levothyroxine

Embed Size (px)

Citation preview

1

Model is for illustrative purposes only.

Welcome to Synthroid Precise Dosing Options

Use1 SYNTHROID® (levothyroxine sodium) tablets, for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

Safety Considerations1

• Thyroid hormones, including SYNTHROID, should not be used for the treatment of obesity or weight loss. Large doses of thyroid hormone, especially when used with certain drugs that reduce appetite, can result in serious and even life-threatening effects.

• Do not use SYNTHROID if you have uncorrected adrenal problems. • Excessive amounts of levothyroxine sodium therapy have been associated with decreased bone strength, especially in

women after menopause. • Talk to your doctor about all medications you are taking, pregnancy plans, and all medical conditions you may have,

especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. Tell your doctor if you are taking SYNTHROID prior to any surgery.

• Tell your doctor if you experience rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.

Look inside for important information to help you stay on track with Synthroid.

25mcg

orange

50mcg

white

75mcg

violet

88mcg

olive

100mcg

yellow

112mcg

rose

125mcg

brown

137mcg

turquoise

150mcg

blue

175mcg

lilac

200mcg

pink

300mcg

green

Tablets shown not actual size and may not represent exact color.

Please see additional Important Safety Information, including BOXED WARNING regarding inappropriate treatment for obesity or for weight loss, on page 5.

Please click here to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

2

Please see additional Important Safety Information, including BOXED WARNING regarding inappropriate treatment for obesity or for weight loss, on page 5.

Please click here to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

Managing hypothyroidism includes getting a precise dose of medicine day after day. This is because levothyroxine products, including Synthroid, are narrow therapeutic index (NTI) drugs. With NTI drugs, if your dose is off even a little bit, you could experience symptoms of under-replacement (not enough medicine) or symptoms of over-replacement (too much medicine).

In the early months of treatment, your doctor may adjust your dose a few times to make sure you’re at the precise dose that’s right for you. In order to determine if your dosage needs to change, you’ll need to monitor your symptoms, and your doctor will run blood tests.

Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.

• Fatigue

• Weight gain or trouble losing weight

• Dry skin

• Yellow skin

• Feeling cold all over

• Feeling down or depressed

• Trouble remembering things

• Decreased appetite

• Hair loss

• Swollen hands or face

• Feeling nervous or jittery

• Weight loss

• Trouble sleeping

• Rapid or irregular heartbeat

• Sweating heavily

• Muscle weakness

• Shortness of breath

• Increased appetite

• Feeling hot all over

Some symptoms of under-replacement (not enough medicine)†2

Some symptoms of over-replacement (too much medicine)†

† This is not a complete list of symptoms that can occur from under-replacement and over-replacement.

Talk to your healthcare provider if you experience any of the following:

Precise dosing—Why it’s important

Safety Considerations

Congratulations on starting Synthroid—the #1 prescribed levothyroxine brand.* For more than 50 years, Synthroid has been helping people like you treat their hypothyroidism.

* IMS weekly prescription volume, December 7, 2012.

Get the most from Synthroid

Identify your symptoms with the Symptom Profiler tool. Access it at: Synthroid.com/Thyroid-Doctor/Symptom-Profiler

3

Please see additional Important Safety Information, including BOXED WARNING regarding inappropriate treatment for obesity or for weight loss, on page 5.

Please click here to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

The Food and Drug Administration has determined that certain levothyroxine products are interchangeable. The FDA has determined that drugs that are classified as interchangeable can be substituted at the pharmacy. A levothyroxine product that is not interchangeable with Synthroid might not have the exact same effect on your TSH as Synthroid.

Interchangeable InterchangeableInterchangeable Not Interchangeable

IF YOUR DOCTOR DOESN’T NOTE “DISPENSE AS WRITTEN” (DAW) ON YOUR PRESCRIPTION, you may get a generic levothyroxine medication instead of Synthroid, like the scenario below. In these cases, you may pay more at the pharmacy if you have to ask for Synthroid.

Refill 4 represents a generic levothyroxine medication that is interchangeable with another generic, like Refill 3, but is NOT interchangeable with Synthroid. This medication might not have the exact same effect on your TSH as Synthroid.

This example may not happen in some states.

Your doctor may write “Dispense as Written” (DAW), or your state’s required language, on your prescription.

IF YOUR DOCTOR CHOOSES SYNTHROID, ASK THAT HE/SHE WRITES “DAW” ON YOUR PRESCRIPTION, indicating “brand name” medication is necessary. That way you’ll pay the lower cost for Synthroid at the pharmacy.

Refill 1 Refill 2 Refill 3 Refill 4

*

Make sure you’re getting the Synthroid your doctor prescribed

Do not use SYNTHROID if you have uncorrected adrenal problems.Safety Considerations

Refill 1 Refill 2 Refill 3 Refill 4

Tablets shown not actual size and may not represent exact color.

4

Please see additional Important Safety Information, including BOXED WARNING regarding inappropriate treatment for obesity or for weight loss, on page 5.

Please click here to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

Learn more about filling your prescription at: Synthroid.com/Medication/Check-Your-Pill

§Patient survey responses collected in 2013. Mistaken Synthroid users (n=300) defined as those who think they are using Synthroid but did not have Synthroid embossed on their actual pill.

25mcg

orange

50mcg

white

75mcg

violet

88mcg

olive

100mcg

yellow

112mcg

rose

125mcg

brown

137mcg

turquoise

150mcg

blue

175mcg

lilac

200mcg

pink

300mcg

green

Tablets shown not actual size and may not represent exact color.

Stay on track

• Use Synthroid only as prescribed by your healthcare provider. Do not discontinue or change the amount you take, or how often you take it, unless directed to do so by your healthcare provider.

• Try not to miss a dose.

• Take Synthroid on an empty stomach, one-half to one hour before breakfast.

• Certain foods can interfere with the way Synthroid works. Let your doctor know if you consume soybean flour (including infant formula), cotton seed meal, walnuts, grapefruit juice or dietary fiber. Your dose of Synthroid may need to be adjusted.

• Don’t take Synthroid within 4 hours of medications or supplements such as antacids, iron or calcium, as these can decrease the absorption of levothyroxine sodium tablets. Learn more at: Synthroid.com/LivingWith/Diet.aspx

To help keep your thyroid running like clockwork, take Synthroid as prescribed every day.

Your healthcare provider may write “Dispense as Written” (DAW), or your state’s required language, on your prescription.

Switches can happen at the pharmacy without your knowledge. 40% of patients who think they are on Synthroid are actually not.§

If your healthcare provider wants you to be on Synthroid, it’s up to you to ensure you get Synthroid at your first prescription fill and every refill.

• Ask for Synthroid by name.

• Check your pills before leaving the pharmacy. If they don’t say “Synthroid,” they’re not Synthroid.

• Speak up. If you didn’t get Synthroid, tell the pharmacist you want to stick with the medication your healthcare provider prescribed.

• Have the pharmacist note your preference for Synthroid for future refills.

Make sure it’s Synthroid if that’s what your doctor prefers

Check your pill. If your pill doesn’t say Synthroid, it is not Synthroid. Go to Synthroid.com/makesure to let us know what you find out.

5

Use and Important Safety Information about Synthroid® (levothyroxine sodium tablets, USP)

Use1 SYNTHROID® (levothyroxine sodium) tablets, for oral use is a prescription, man-made thyroid hormone that is used to treat a condition called hypothyroidism. It is meant to replace a hormone that is usually made by your thyroid gland. Generally, thyroid replacement treatment is to be taken for life. SYNTHROID should not be used to treat noncancerous growths or enlargement of the thyroid in patients with normal iodine levels, or in cases of temporary hypothyroidism caused by inflammation of the thyroid gland (thyroiditis).

Important Safety Information1

• Thyroid hormones, including SYNTHROID, should not be used either alone or in combination with other drugs for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of SYNTHROID used daily for hormone replacement are not helpful for weight loss. Larger doses may result in serious or even life-threatening events, especially when used in combination with certain other drugs used to reduce appetite.

• Do not use SYNTHROID if you have uncorrected adrenal problems.

• Taking too much levothyroxine has been associated with increased bone loss, especially in women after menopause.

• Once your doctor has found your specific SYNTHROID dose, it is important to have lab tests done, as ordered by your doctor, at least once a year.

• Foods like soybean flour, cottonseed meal, walnuts, and dietary fiber may cause your body to absorb less SYNTHROID from the gastrointestinal tract. Grapefruit juice may cause your body to absorb less levothyroxine and may reduce its effect. Let your doctor know if you eat these foods, as your dose of SYNTHROID may need to be adjusted.

• Use SYNTHROID only as ordered by your doctor. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.

• Products such as iron and calcium supplements and antacids can lower your body’s ability to absorb levothyroxine, so SYNTHROID should be taken 4 hours before or after taking these products.

• Tell your doctor if you are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID. Your dose of SYNTHROID may need to be increased during your pregnancy.

• It may take several weeks before you notice an improvement in your symptoms.

• Tell your doctor if you are taking any other drugs, including prescription and over-the-counter products.

• Tell your doctor about any other medical conditions you may have, especially heart disease, diabetes, blood clotting problems, and adrenal or pituitary gland problems. The dose of other drugs you may be taking to control these conditions may have to be changed while you are taking SYNTHROID. If you have diabetes, check your blood sugar levels and/or the glucose in your urine, as ordered by your doctor, and immediately tell your doctor if there are any changes. If you are taking blood thinners, your blood clotting status should be checked often.

• Tell your doctor or dentist that you are taking SYNTHROID before any surgery.

• Tell your doctor if you develop any of the following symptoms: rapid or abnormal heartbeat, chest pain, difficulty catching your breath, leg cramps, headache, nervousness, irritability, sleeplessness, shaking, change in appetite, weight gain or loss, vomiting, diarrhea, increased sweating, difficulty tolerating heat, fever, changes in menstrual periods, swollen red bumps on the skin (hives) or skin rash, or any other unusual medical event.

• Partial hair loss may occur during the first few months you are taking SYNTHROID.

This is the most important safety information you should know about SYNTHROID. For more information, talk with your doctor.

Please click to see full Prescribing Information, or visit http://www.rxabbvie.com/pdf/Synthroid.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact www.pparx.org for assistance.

References: 1. Synthroid [package insert]. 2. Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism. Endocr Pract. 2002;8(6):457-469.

©2016 AbbVie Inc. North Chicago, IL 60064 605-1898745 December 2016