Ryzodeg Flextouch Pre Filled Pen

Uses of Ryzodeg Flextouch Pre-Filled Pen

• Type I Diabetes mellitus
• Type II Diabetes Mellitus

How does Ryzodeg Flextouch Pre-Filled Pen work?

This medicine is a replacement insulin that works by enhancing the glucose uptake for energy production. This helps in controlling the blood glucose levels.

Side Effects of Ryzodeg Flextouch Pre-Filled Pen

Injection site reactions, lipodystrophy, lumps under the skin, weight gain, swelling of body parts, and hypoglycemia are common side effects of Ryzodeg Flextouch Pre-Filled Pen. However, if you experience any of the following severe side effects, consult your doctor immediately:

1. Allergic reaction: This may include generalized skin rash with itching, sweating, swelling of layers under the skin, difficulties in breathing, palpitation, vomiting, stomach upset, reduction in blood pressure, and fainting.
2. Signs of severe hypoglycemia: These may include cold sweats, cool pale skin, headache, rapid heartbeat, nausea, increased hunger, temporary vision changes, drowsiness, tiredness and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.
3. Signs of heart failure: These may include shortness of breath, edema, and rapid weight gain.

If you experience any of these severe side effects, it is important to seek immediate medical attention.

Quick Suggestions:

• Ryzodeg Flextouch Pre-Filled Pen 100IU should not be mixed with any other insulins before use.
• Do not stop therapy with Ryzodeg Flextouch Pre-Filled Pen 100IU without consulting your doctor.
• Your doctor will determine the correct dose and frequency of administration based on factors such as age, body weight, and health condition.

Indication of Ryzodeg Flextouch Pre-Filled Pen

Insulin degludec and insulin aspart are both analogs of human insulin, with insulin degludec being a long-acting insulin analog and insulin aspart being a rapid-acting insulin analog. They are indicated to improve glycemic control in patients aged 1 year and older with diabetes mellitus.

Pharmacology

Both insulin degludec and insulin aspart bind specifically to the human insulin receptor, resulting in the same pharmacological effects as human insulin. These effects primarily involve the regulation of glucose levels in the blood.

The blood glucose-lowering effect of insulin occurs through several mechanisms. First, insulin facilitates the uptake of glucose by cells, particularly muscle and fat cells, which allows glucose to be utilized for energy production. Additionally, insulin inhibits the release of glucose from the liver into the bloodstream, further contributing to the reduction of blood glucose levels.

By mimicking the action of endogenous insulin, insulin degludec and insulin aspart help to regulate blood glucose levels and improve glycemic control in patients with diabetes mellitus.

Dosage & Administration of Ryzodeg Flextouch Pre-Filled Pen

The dosage and administration instructions for the Ryzodeg Flextouch Pre-Filled Pen are as follows:

Dosage:

• Ryzodeg Flextouch Pre-Filled Pen 100IU is a soluble insulin product containing both basal insulin degludec and rapid-acting prandial insulin aspart.
• The dosage should be tailored according to the individual patient's needs.
• Dosage adjustments are primarily recommended based on fasting plasma glucose measurements.
• For patients with type 2 diabetes mellitus, the recommended total daily starting dose is 10 units with meal(s), followed by individual dosage adjustments.
• For patients with type 1 diabetes mellitus, the recommended starting dose is 60-70% of the total daily insulin requirements. This should be used once daily at meal-time in combination.

Administration:

• Use Ryzodeg Flextouch Pre-Filled Pen 100IU under careful medical supervision.
• Inject Ryzodeg Flextouch Pre-Filled Pen 100IU subcutaneously into your thighs, buttocks, upper arm, or abdomen.
• Do not administer this medicine into the vein or muscle directly.
• Administer at least 10 minutes before meals.
• Consume a meal or snack containing carbohydrates within 20 minutes of the injection to avoid low blood sugar.
• Before administration, roll the vial/cartridge between your hands until the liquid becomes uniformly white and cloudy.
• Keep the needle under the skin for at least 6 seconds while injecting to ensure the entire dose is administered.
• Visually inspect the cartridge/vial for any visible particulate matter and discoloration before administration.
• Discard the needle and syringe after use, and do not share your needles with others to prevent the risk of transmission of infections.
• Avoid repeatedly injecting the medicine at the same site to prevent skin damage. Rotate the injection site as instructed by your doctor.

Interaction

It's crucial to be aware of potential interactions between medications, as well as between medications and other substances like alcohol. Here's a summary of the interactions associated with Ryzodeg FlexTouch Pre-Filled Pen:

Interaction with Alcohol:

• Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of both hypoglycemia (low blood glucose levels) and hyperglycemia (high blood glucose levels).
• Depending on the quantity and frequency of alcohol consumption, this may lead to severe side effects such as dizziness, drowsiness, increased thirst, increased hunger, mood changes, and extreme fatigue.

Interaction with Medicine:

• Corticosteroids
• Beta blockers
• ACE inhibitors
• Gatifloxacin
• Fluoroquinolones
• Aspirin

Disease Interactions:

• Kidney Disease: Caution is advised in patients with a history of kidney diseases due to the increased risk of severe adverse effects. Close monitoring of blood glucose levels is recommended, and appropriate dose adjustments may be necessary.
• Hypokalemia: Patients at an increased risk of developing hypokalemia (decreased blood potassium levels) or those suffering from hypokalemia should use this medicine with caution, as it may worsen their condition. Appropriate corrective measures, dose adjustments, or alternative medications may be required.
• Liver Disease: Caution is advised in patients with a history of liver diseases due to the increased risk of severe adverse effects. Close monitoring of blood glucose levels is recommended, and appropriate dose adjustments may be necessary.

Contraindications

Hypersensitivity to the active substances or any of the excipients.

Pregnancy & Lactation

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant the use of the drug in pregnant women despite potential risks There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous insulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production. 

Precautions & Warnings

• The omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia. This can also occur if the insulin dose is too high relative to the insulin requirement. Patients with concomitant illnesses, especially infections and fever, typically experience an increased insulin requirement. Patients with kidney, liver, adrenal, pituitary, or thyroid gland diseases may require adjustments in insulin dose to manage hypoglycemia.
• Administration of rapid-acting insulin is recommended for severe hyperglycemia. Inadequate dosing or discontinuation of insulin treatment in patients who require it may lead to hyperglycemia and potentially diabetic ketoacidosis. Concomitant illnesses, particularly infections, can also lead to hyperglycemia by increasing insulin requirements.
• Abrupt improvement in glycemic control with intensified insulin therapy may temporarily worsen diabetic retinopathy. However, long-term improved glycemic control reduces the risk of progression of diabetic retinopathy.
• Patients must always check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg FlexTouch Pre-Filled Pen and other insulin products.
• Ryzodeg can be used in older patients. However, glucose monitoring should be intensified, and insulin doses adjusted on an individual basis.
• Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties. Safety and efficacy have not been fully investigated in children and adolescents. Therefore, caution should be exercised when using this medication in pediatric patients.

Storage Conditions

• Keep out of reach of children
• Store the unopened pack in the refrigerator at 2-8°C. Do not freeze
• During use or when carried as a spare, keep it at room temperature
• Always place the vial/cartridge in the outer carton to protect it from light
• Do not use the medicine after 28 days of opening