Ryzodeg 70/30

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of Ryzodeg® contains a patient information sheet. Read this sheet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

The insulin solution should look clear and colorless. Do not use it if it is cloudy or thickened. Do not mix this medicine with any other insulin or with water.

Take this medicine with any main meal. You may also use a fast- or short-acting insulin with other meals, if needed.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For Type 1 diabetes:
    • Adults and children 1 year of age and older—Dose is based on your blood sugar and must be determined by your doctor.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.
  • For Type 2 diabetes:
    • Adults and children 1 year of age and older—Dose is based on your blood sugar and must be determined by your doctor.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose, take your next dose with your next main meal on the same day and continue with your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

You may keep the unopened FlexTouch disposable prefilled pen in the refrigerator until the expiration date on the carton, or at room temperature for up to 28 days. Protect from light. Do not freeze.

Store the FlexTouch disposable prefilled pen that you are currently using at room temperature in a cool place, away from direct heat and light, for up to 28 days. Do not refrigerate.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

• Cough
• decreased urine
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• hives, itching, or skin rash
• increased thirst
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears
• sweating
• tightness in the chest
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• ear congestion
• fever
• loss of voice
• muscle aches
• sneezing
• stuffy or runny nose

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

• Redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Ryzodeg contains a combination of insulin aspart and insulin degludec. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting insulin. Insulin degludec is a long-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in about 1 hour, and keeps working for 24 hours or longer.

Ryzodeg is used to improve blood sugar control in adults with diabetes mellitus.

Ryzodeg may be used for type 1 or type 2 diabetes.

You should not use Ryzodeg if you are having an episode of hypoglycemia (low blood sugar).

Never share a Ryzodeg injection pen with another person, even if the needle has been changed.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of an allergic reaction to Ryzodeg: hives, itching, skin rash; wheezing, tiredness, trouble breathing; feeling like you might pass out; nausea, diarrhea; swelling of your face, lips, tongue, or throat.

Call your doctor if you have:

• fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common Ryzodeg side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to insulin aspart / insulin degludec: subcutaneous solution

Along with its needed effects, insulin aspart / insulin degludec may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin aspart / insulin degludec:

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

• Cough
• decreased urine
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• hives, itching, or skin rash
• increased thirst
• irregular heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears
• sweating
• tightness in the chest
• vomiting

Some side effects of insulin aspart / insulin degludec may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• ear congestion
• fever
• loss of voice
• muscle aches
• sneezing
• stuffy or runny nose

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

• Redistribution or accumulation of body fat

Applies to insulin aspart / insulin degludec: subcutaneous solution

General

The most frequently reported adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.[Ref]

Metabolic

Weight gain, attributed to the anabolic effects of insulin, has been reported. In clinical trials, an average weight gain of 1.6 kg and 2.8 kg was reported in patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]

Very common (10% or more): Hypoglycemia (up to 95%)
Frequency not reported: Weight gain[Ref]

Immunologic

The incidence of insulin degludec-aspart anti-insulin antibodies has not been established. The detection of antibodies is dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies may be misleading. In a study in patients with type 1 diabetes, almost 96% of patients were positive for insulin degludec-aspart anti-insulin antibodies at least once during the studies, including almost 89% at baseline; while 13% were positive for insulin aspart anti-insulin antibodies at least once during the studies, including 6.4% at baseline.[Ref]

Common (1% to 10%): Influenza
Frequency not reported: Anti-insulin antibodies[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema[Ref]

In clinical trials, peripheral edema was reported in 2.2% and 1.8% of patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching; urticaria[Ref]

Local

Common (1% to 10%): Injection site reactions including hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass
Uncommon (0.1% to 1%): Lipodystrophy[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 24.6%)
Common (1% to 10%): Upper respiratory tract infection[Ref]

Nervous system

Common (1% to 10%): Headache

Some side effects of Ryzodeg 70 / 30 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.