What happens if I overdose Galactus?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.
Proper storage of Galactus cartridge systems:
Store new (unopened) cartridge systems in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Galactus cartridge systems. Store used (open) cartridge systems at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges in the refrigerator. Store away from heat and light. If Galactus cartridge systems has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems after 28 days, even if they still contain medicine.
Do not leave Galactus cartridge systems in a car on a warm or sunny day. Do not use Galactus cartridge systems after the expiration date stamped on the label. Throw away used cartridge systems 28 days after the first use, even if they still contain medicine. Keep Galactus cartridge systems, as well as syringes and needles, out of the reach of children and away from pets.
Overdose of Galactus in details
An excess of insulin relative to food intake, energy expenditure or both may lead to severe and sometimes long-term and life-threatening hypoglycemia.
Mild episodes of hypoglycemia can usually be treated with oral glucose/carbohydrates. Adjustments in drug dosage, meal patterns or exercise may be needed.
More severe episodes with coma, seizure or neurologic impairment may be treated with IM/SC glucagon or concentrated IV glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.
It is, therefore, recommended that the diabetic patient constantly carry some sugar lumps, sweets, biscuits or sugary fruit juice. Adjustments in drug dosage, meal patterns or exercise may be needed.
What should I avoid while taking Galactus?
While using Galactus do not:
- drive or operate heavy machinery, until you know how Galactus affects you.
- drink alcohol or use over-the counter medicines that contain alcohol.
Galactus warnings
Never Share a Galactus SoloStar pen Between Patients
Galactus SoloStar disposable prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant oral anti-diabetic products may be needed.
On a unit to unit basis, Galactus has a lower glucose lowering effect than LANTUS. In clinical trials, patients who changed to Galactus from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. To minimize the risk of hyperglycemia when initiating Galactus monitor glucose daily, titrate Galactus according to labeling instructions, and adjust co-administered glucose lowering therapies per standard of care. Higher doses of Galactus were required to achieve similar levels of glucose control compared to LANTUS in clinical trials.
The onset of action of Galactus develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of Galactus before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days.
Hypoglycemia
Hypoglycemia is the most common adverse reaction associated with insulin, including Galactus. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation.
As with all insulin preparations, the glucose lowering effect time course of Galactus may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
Risk Mitigation Strategies for Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. To minimize the risk of hypoglycemia do not administer Galactus intravenously, intramuscularly or in an insulin pump or dilute or mix Galactus with any other insulin products or solutions.
Medication Errors
Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between Galactus and other insulins, instruct patients to always check the insulin label before each injection.
Hypersensitivity and Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Galactus. If hypersensitivity reactions occur, discontinue Galactus; treat per standard of care and monitor until symptoms and signs resolve. Galactus is contraindicated in patients who have had hypersensitivity reactions to Galactus or other of the excipients.
Hypokalemia
All insulin products, including Galactus, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Galactus, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
What should I discuss with my healthcare provider before taking Galactus?
Some medical conditions may interact with Galactus cartridge systems. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you drink alcoholic beverages
- if you have heart problems (eg, heart failure), liver or kidney problems, diabetic ketoacidosis, or nerve problems
- if you have high blood sodium levels or are on a low salt diet
Some MEDICINES MAY INTERACT with Galactus cartridge systems. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Thiazolidinediones (eg, pioglitazone, rosiglitazone) because the risk of heart failure may be increased
- Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, ritonavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Galactus cartridge systems's effectiveness, resulting in high blood sugar
This may not be a complete list of all interactions that may occur. Ask your health care provider if Galactus cartridge systems may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Galactus precautions
Never Share A Galactus SoloStar Pen Between Patients
Galactus SoloStar disposable prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia Or Hypoglycemia With Changes In Insulin Regimen
Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant oral anti-diabetic products may be needed.
On a unit to unit basis, Galactus has a lower glucose lowering effect than LANTUS. In clinical trials, patients who changed to Galactus from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. To minimize the risk of hyperglycemia when initiating Galactus monitor glucose daily, titrate Galactus according to labeling instructions, and adjust co-administered glucose lowering therapies per standard of care. Higher doses of Galactus were required to achieve similar levels of glucose control compared to LANTUS in clinical trials.
The onset of action of Galactus develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of Galactus before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days.
Hypoglycemia
Hypoglycemia is the most common adverse reaction associated with insulin, including Galactus. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent hypoglycemia.
Risk Factors For Hypoglycemia
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin preparations, the glucose lowering effect time course of Galactus may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
Risk Mitigation Strategies For Hypoglycemia
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. To minimize the risk of hypoglycemia do not administer Galactus intravenously, intramuscularly or in an insulin pump or dilute or mix Galactus with any other insulin products or solutions.
Medication Errors
Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between Galactus and other insulins, instruct patients to always check the insulin label before each injection.
Hypersensitivity And Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Galactus. If hypersensitivity reactions occur, discontinue Galactus; treat per standard of care and monitor until symptoms and signs resolve. Galactus is contraindicated in patients who have had hypersensitivity reactions to Galactus or other of the excipients.
Hypokalemia
All insulin products, including Galactus, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Fluid Retention And Heart Failure With Concomitant Use Of PPAR-gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Galactus, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
Patient Counseling Information
General Counseling Information—Prior to treatment, patients should fully understand the risks and benefits of Galactus. Ensure that all patients receive the Instruction Leaflet prior to initiating Galactus therapy.
Never Share A Galactus SoloStar Pen Between Patients
Advise patients that they must never share Galactus SoloStar pen with another person even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia Or Hypoglycemia
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.
Advise patients that changes in insulin regimen can predispose to hyper- or hypoglycemia. Advise patients that changes in insulin regimen should be made under close medical supervision. Inform patients that if they change to Galactus from other basal insulins they may experience higher average fasting plasma glucose levels in the first weeks of therapy. Advise patients to monitor glucose daily when initiating Galactus.
Medication Errors
Instruct patients to always check the insulin label before each injection. The “300 Units/mL (U-300)” is highlighted in honey gold on the label of Galactus SoloStar disposable prefilled pen.
Inform patients that Galactus (Galactus 300 U/mL) contains 3 times as much insulin in 1 mL as standard insulin (100 U/mL).
Inform patients that the dose counter of Galactus SoloStar disposable prefilled pen shows the number of units of Galactus to be injected. No dose re-calculation is required.
Instruct patients to not re-use needles. A new needle must be attached before each injection. Re-use of needles increases the risk of blocked needles which may cause under-dosing or overdosing. In the event of blocked needle, the patients must follow the instructions described in Step 3 of the Instructions for Use.
Instruct Patients to never use a syringe to remove Galactus from the SoloStar disposable insulin prefilled pen.
Administration
Galactus must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that Galactus must NOT be diluted or mixed with any other insulin or solution.
Management Of Hypoglycemia And Handling Of Special Situations
Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.
Pregnancy
Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy.
Refer patients to the Galactus “PATIENT INFORMATION“ for additional information about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia.
FDA Approved Patient Labeling
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In mice and rats, standard two-year carcinogenicity studies with Galactus were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day). The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.
Galactus was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames- and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).
In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day), maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
Use In Specific Populations
Pregnancy
Risk Summary
All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes, insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking Galactus.
Human data
There are no clinical studies of the use of Galactus in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal data
Subcutaneous reproduction and teratology studies have been performed with Galactus and regular human insulin in rats and Himalayan rabbits. Galactus was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day). In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day), were administered during organogenesis. The effects of Galactus did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
Nursing Mothers
Endogenous insulin is present in human milk; it is unknown whether Galactus is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when Galactus is administered to a nursing woman. Use of Galactus is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.
Pediatric Use
The safety and effectiveness of Galactus have not been established in pediatric patients.
Geriatric Use
In controlled clinical studies, 30 of 304 (9.8%) Galactus treated patients with type 1 diabetes and 327 of 1242 (26.3%) Galactus treated patients with type 2 diabetes were ≥ 65 years of age, among them 2.0 % of the patients with type 1 and 3.0% of the patients with type 2 diabetes were ≥ 75 years of age. No overall differences in effectiveness and safety were observed in the subgroup analyses across the age groups.
Nevertheless, caution should be exercised when Galactus is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of Galactus has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for Galactus in patients with hepatic impairment.
Renal Impairment
The effect of renal impairment on the pharmacokinetics of Galactus has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Frequent glucose monitoring and dose adjustment may be necessary for Galactus in patients with renal impairment.
Obesity
No overall differences in effectiveness and safety were observed in subgroup analyses based on BMI.
What happens if I miss a dose of Galactus?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. You should not use more than one dose in a 24-hour period unless your doctor tells you to.
Keep Galactus on hand at all times. Get your prescription refilled before you run out of medicine completely.
References
- DrugBank. "Insulin Glargine - DrugBank". http://www.drugbank.ca/drugs/DB00047 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
