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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 11.06.2022
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Apidra Solostar Pens is an antidiabetic agent, used to reduce high blood sugar in adults, adolescents and children ≥6 years with diabetes mellitus. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.
Apidra Solostar Pens is a fast-acting type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus (sugar diabetes), your body cannot make enough insulin or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in the blood can be harmful to your health.
Apidra Solostar Pens starts to work faster than some other types of insulin, and its effects do not last as long. It should act more like the insulin your body would normally produce. Because the effects of Apidra Solostar Pens are short-acting, your doctor may also prescribe a longer-acting insulin for you to use.
Apidra Solostar Pens is available only with your doctor's prescription.
Dosage considerations
Apidra Solostar Pens is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Apidra Solostar Pens has the same glucose-lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Apidra Solostar Pens has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of Apidra Solostar Pens must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.
The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
Subcutaneous administration
Apidra Solostar Pens should be given within 15 minutes before a meal or within 20 minutes after starting a meal.
Apidra Solostar Pens given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin.
Apidra Solostar Pens should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophy.
Continuous subcutaneous infusion (insulin pump)
Apidra Solostar Pens may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen.
The following insulin pumps1 have been used in Apidra Solostar Pens clinical trials conducted by sanofi-aventis, the manufacturer of Apidra Solostar Pens:
- Disetronic® H-Tron® plus V100 and D-Tron® with Disetronic catheters (Rapid™, Rapid C™, Rapid D™, and Tender™)
- MiniMed® Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate QR™, and Quick-set™).
Before using a different insulin pump with Apidra Solostar Pens, read the pump label to make sure the pump has been evaluated with Apidra Solostar Pens.
Physicians and patients should carefully evaluate information on pump use in the Apidra Solostar Pens prescribing information, Patient Information Leaflet, and the pump manufacturer's manual. Apidra Solostar Pens-specific information should be followed for in-use time, frequency of changing infusion sets, or other details specific to Apidra Solostar Pens usage, because Apidra Solostar Pens-specific information may differ from general pump manual instructions. Failure to follow Apidra Solostar Pens-specific instructions may lead to serious adverse events.
Patients administering Apidra Solostar Pens by continuous subcutaneous infusion must have an alternative insulin delivery system in case of pump system failure.
Based on in vitro studies which have shown loss of the preservative, metacresol and insulin degradation, Apidra Solostar Pens in the reservoir should be changed at least every 48 hours. Apidra Solostar Pens should not be exposed to temperatures greater than 98.6°F (37°C).
In clinical use, the infusion sets and the Apidra Solostar Pens in the reservoir must be changed at least every 48 hours.
Intravenous administration
Apidra Solostar Pens can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Apidra Solostar Pens should be used at concentrations of 0.05 Units/mL to 1 Unit/mL Apidra Solostar Pens in infusion systems using polyvinyl chloride (PVC) bags. Apidra Solostar Pens has been shown to be stable only in normal saline solution (0.9% sodium chloride).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.
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What is the most important information I should know about Apidra Solostar Pens?
Apidra Solostar Pens is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.
Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.
Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.
Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.
Apidra Solostar Pens is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Use Apidra Solostar Pens vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Apidra Solostar Pens vials. Talk to your pharmacist if you have questions about this information.
- Use Apidra Solostar Pens vials within 15 minutes before a meal or within 20 minutes after starting a meal, unless directed otherwise by your doctor.
- If you will be using Apidra Solostar Pens vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Apidra Solostar Pens vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- You may use Apidra Solostar Pens vials in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Apidra Solostar Pens vials or mix it together with any other type of insulin.
- Apidra Solostar Pens vials should be clear and colorless. Do not use Apidra Solostar Pens vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you are mixing Apidra Solostar Pens vials with NPH insulin, draw Apidra Solostar Pens vials into the syringe first. Inject the dose immediately after mixing, as directed by your doctor. Do not mix Apidra Solostar Pens vials with any other type of insulin except NPH.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
- Injection sites within an injection area (abdomen, thigh, upper arm) must be rotated from one injection to the next.
- Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.
- Apidra Solostar Pens vials begins lowering blood sugar within minutes after an injection. The peak effect occurs between 30 and 90 minutes after a dose. The effect usually lasts from 1 to 2½ hours.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.
Ask your health care provider any questions you may have about how to use Apidra Solostar Pens vials.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Diabetes mellitus, types 1 and 2: Treatment of type 1 diabetes mellitus and type 2 diabetes mellitus to improve glycemic control
Off Label Uses
Diabetic ketoacidosis
Data from a prospective, randomized open label trial in a limited number of patients with diabetic ketoacidosis (DKA) comparing the use of IV Apidra Solostar Pens to a standard IV infusion protocol of regular insulin supports the use of Apidra Solostar Pens in the treatment of diabetic ketoacidosis.
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What other drugs will affect Apidra Solostar Pens?
Studies on pharmacokinetic interactions have not been performed. Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
A number of substances affect glucose metabolism and may require dose adjustment of Apidra Solostar Pens and particularly close monitoring.
Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents [eg, epinephrine (adrenaline), salbutamol, terbutaline], thyroid hormones, estrogens, progestins (eg, in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (eg, olanzapine and clozapine).
β-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering activity of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.
In addition, under the influence of sympatholytic medicinal products eg, β-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Incompatibilities: In the absence of compatibility studies, Apidra Solostar Pens must not be mixed with other medicinal products except neutral protamine hagedorn (NPH) human insulin.
See also:
What are the possible side effects of Apidra Solostar Pens?
The following adverse reactions are discussed elsewhere:
- Hypoglycemia
- Hypokalemia
Clinical Trial experience
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
The frequencies of adverse drug reactions during Apidra Solostar Pens clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
Table 1: Treatment –emergent adverse events in pooled studies of adults with type 1 diabetes (adverse events with frequency ≥ 5%)
Apidra Solostar Pens, % (n=950) | All comparators Only severe symptomatic hypoglycemia |
Table 2: Treatment –emergent adverse events in pooled studies of adults with type 2 diabetes (adverse events with frequency ≥ 5%)
Apidra Solostar Pens, % (n=883) | Regular human insulin, % (n=883) | |
Upper respiratory tract infection | 10.5 | 7.7 |
Nasopharyngitis | 7.6 | 8.2 |
Edema peripheral | 7.5 | 7.8 |
Influenza | 6.2 | 4.2 |
Arthralgia | 5.9 | 6.3 |
Hypertension | 3.9 | 5.3 |
Pediatrics
Table 3 summarizes the adverse reactions occurring with frequency higher than 5% in a clinical study in children and adolescents with type 1 diabetes treated with Apidra Solostar Pens (n=277) or insulin lispro (n=295).
Table 3: Treatment –emergent adverse events in children and adolescents with type 1 diabetes (adverse reactions with frequency ≥ 5%)
Apidra Solostar Pens, % (n=277) | Lispro, % (n=295) | |
Nasopharyngitis | 9.0 | 9.5 |
Upper respiratory tract infection | 8.3 | 10.8 |
Headache | 6.9 | 11.2 |
Hypoglycemic seizure | 6.1 | 4.7 |
Severe symptomatic hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Apidra Solostar Pens. The rates and incidence of severe symptomatic hypoglycemia, defined as hypoglycemia requiring intervention from a third party, were comparable for all treatment regimens. In the phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to adults with type 1 diabetes..
Table 4: Severe Symptomatic Hypoglycemia*
Type 1 Diabetes Adults 12 weeks with insulin glargine | Type 1 Diabetes Adults 26 weeks with insulin glargine | Type 2 Diabetes Adults 26 weeks with NPH human insulin | Type 1 Diabetes Pediatrics 26 weeks | ||||||
Apidra Solostar Pens Pre-meal | Apidra Solostar Pens Post-meal | Regular Human Insulin | Apidra Solostar Pens | Insulin Lispro | Apidra Solostar Pens | Regular Human Insulin | Apidra Solostar Pens | Insulin Lispro | |
Events per month per patient | 0.05 | 0.05 | 0.13 | 0.02 | 0.02 | 0.00 | 0.00 | 0.09 | 0.08 |
Percent of patients (n/total N) | 8.4% (24/286) | 8.4% (25/296) | 10.1% (28/278) | 4.8% (16/339) | 4.0% (13/333) | 1.4% (6/416) | 1.2% (5/420) | 16.2% (45/277) | 19.3% (57/295) |
* Severe symptomatic hypoglycemia defined as a hypoglycemic event requiring the assistance of another person that met one of the following criteria: the event was associated with a whole blood referenced blood glucose < 36mg/dL or the event was associated with prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. |
Insulin initiation and intensification of glucose control
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Lipodystrophy
Long-term use of insulin, including Apidra Solostar Pens, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy..
Weight gain
Weight gain can occur with insulin therapy, including Apidra Solostar Pens, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Peripheral Edema
Insulin, including Apidra Solostar Pens, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
In a 12-week randomized study in patients with type 1 diabetes (n=59), the rates of catheter occlusions and infusion site reactions were similar for Apidra Solostar Pens and insulin aspart treated patients (Table 5).
Table 5: Catheter Occlusions and Infusion Site Reactions.
40% | Apidra Solostar Pens (n=29) | insulin aspart (n=30) |
Catheter occlusions/month | 0.08 | 0.15 |
Infusion site reactions | 10.3% (3/29) | 13.3% (4/30) |
Allergic Reactions
Local Allergy
As with any insulin therapy, patients taking Apidra Solostar Pens may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions may require discontinuation of Apidra Solostar Pens. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.
Systemic Allergy
Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including Apidra Solostar Pens. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
In controlled clinical trials up to 12 months duration, potential systemic allergic reactions were reported in 79 of 1833 patients (4.3%) who received Apidra Solostar Pens and 58 of 1524 patients (3.8%) who received the comparator short-acting insulins. During these trials treatment with Apidra Solostar Pens was permanently discontinued in 1 of 1833 patients due to a potential systemic allergic reaction.
Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient of Apidra Solostar Pens.
Antibody Production
In a study in patients with type 1 diabetes (n=333), the concentrations of insulin antibodies that react with both human insulin and Apidra Solostar Pens (cross-reactive insulin antibodies) remained near baseline during the first 6 months of the study in the patients treated with Apidra Solostar Pens. A decrease in antibody concentration was observed during the following 6 months of the study. In a study in patients with type 2 diabetes (n=411), a similar increase in cross-reactive insulin antibody concentration was observed in the patients treated with Apidra Solostar Pens and in the patients treated with human insulin during the first 9 months of the study. Thereafter the concentration of antibodies decreased in the Apidra Solostar Pens patients and remained stable in the human insulin patients. There was no correlation between cross-reactive insulin antibody concentration and changes in HbA1c, insulin doses, or incidence of hypoglycemia. The clinical significance of these antibodies is not known.
Apidra Solostar Pens did not elicit a significant antibody response in a study of children and adolescents with type 1 diabetes.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Apidra Solostar Pens.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of Apidra Solostar Pens.
Each mL contains Insulin Glulisine 100 units (equivalent to 3.49 mg).
Each pen contains 3 mL of soln for injection, equivalent to 300 units.
Apidra Solostar Pens also contains the following excipients: Metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide and water for injections.
Apidra Solostar Pens is produced by recombinant deoxyribonucleic acid (DNA) technology in Escherichia coli.