• Galactus indications
• Uses of Galactus in details
• Galactus description
• Galactus dosage
• Galactus interactions
• Galactus side effects
• Galactus contraindications

What is Galactus?

Galactus (Galactus) is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Galactus is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

The Galactus SoloStar injection pen is used to improve blood sugar control in adults with diabetes mellitus.

Galactus is used to treat type 1 diabetes or type 2 diabetes in adults.

It is not known if Galactus is safe and effective in children.

Galactus indications

Galactus injection is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of Use

Galactus injection is not recommended for the treatment of diabetic ketoacidosis.

How should I use Galactus?

Use Galactus cartridge systems as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Extra patient leaflets are available with Galactus cartridge systems. Talk to your pharmacist if you have questions about this information.
• Use Galactus cartridge systems at the same time each day, as directed by your doctor.
• A health care provider will teach you how to use Galactus cartridge systems. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Wash your hands before you use Galactus cartridge systems.
• Always check before each use to be sure you are injecting the correct dose of insulin. Using too much or too little insulin may result in serious side effects.
• Galactus cartridge systems should be clear and colorless. Do not use Galactus cartridge systems if it contains particles or is discolored, or if the container is cracked or damaged.
• Do NOT dilute Galactus cartridge systems or mix it with other insulin. Do NOT use it in an insulin pump.
• 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, or 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.
• The effect of Galactus cartridge systems lasts for up to 24 hours.
• Galactus cartridge systems begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.
• Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.
• Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• Keep this product, as well as syringes and needles, out of the reach of children and 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 Galactus cartridge systems.

Uses of Galactus in details

Galactus is used to reduce high blood sugar (glucose) levels in people with diabetes mellitus.

Galactus description

Each mL contains 100 IU Galactus, 0.27% w/v m-cresol as preservative and water for injection.

Galactus injection [ribosomal deoxyribonucleic acid (rDNA)] is a recombinant human insulin analogue produced by recombinant DNA technology. Galactus differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and 2 arginines are added to the C-terminus of B-chain.

Chemically, it is 21^A-Gly-30^Ba-L-Arg-30^Bb-L-Arg-human insulin and has the empirical formula C₂₆₇H₄₀₄N₇₂O₇₈S₆ and a molecular weight of 6,063.

Galactus is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing.

Galactus dosage

Galactus Dosage

Generic name: Galactus 100[iU] in 1mL

Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Important Administration Instructions

• Always check insulin labels before administration.
• Train patients on proper use and injection technique before initiating Galactus.
• Visually inspect Galactus KwikPen for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
• ​Inject between 1 and 80 units per injection.
• Administer Galactus subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy.
• Do not dilute or mix Galactus with any other insulin or solution as the onset of action or time to peak effect of Galactus and the mixed insulin may be altered in an unpredictable manner.
• Do not administer intravenously or via an insulin pump because this could result in severe hypoglycemia.

General Dosing Instructions

• In patients with type 1 diabetes, Galactus must be used concomitantly with short-acting insulin.
• Inject Galactus subcutaneously once daily at any time of day but at the same time every day.
• Individualize and titrate the dosage of Galactus based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function and should be made under medical supervision with appropriate glucose monitoring.

Initiation of Galactus Therapy

• The recommended starting dose of Galactus in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short- or rapid-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
• The recommended starting dose of Galactus in patients with type 2 diabetes is 0.2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short- or rapid-acting insulins and dosages of any anti-diabetic drugs.

Changing to Galactus from Other Insulin Therapies

• If changing patients from another Galactus product, 100 units/mL, to Galactus, the dose of Galactus should be the same as the other Galactus product, 100 units/mL, and the time of day for administration should be determined by the physician.
• If changing patients from a once-daily Galactus product, 300 units/mL, to once-daily Galactus, the recommended initial Galactus dosage is 80% of the Galactus product, 300 units/mL, dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.
• If changing from a treatment regimen with an intermediate- or long-acting insulin (other than an Galactus product, 100 units/mL) to a regimen with Galactus, a change in the dose of the basal insulin may be required and the amount and timing of shorter-acting insulins and doses of any anti-diabetic drugs may need to be adjusted.
• If changing patients from twice-daily NPH insulin to once-daily Galactus, the recommended initial Galactus dosage is 80% of the total NPH dosage that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.

More about Galactus (Galactus)

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Interactions
• Support Group
• En Espanol
• 0 Reviews - Add your own review/rating

Consumer resources

• Galactus
• Galactus KwikPen
• Galactus (Advanced Reading)

• Other brands: Lantus, Galactus, Galactus Solostar, Lantus Solostar

Professional resources

• Galactus (FDA)
• Galactus (AHFS Monograph)

Related treatment guides

• Diabetes, Type 1
• Diabetes, Type 2

Galactus interactions

See also:
What other drugs will affect Galactus?

Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with Galactus use may be increased with antidiabetic agents, (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when Galactus is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of Galactus

The glucose lowering effect of Galactus may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isonazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when Galactus is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of Galactus

The glucose lowering effect of Galactus may be increased or decreased when co-administered with alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when Galactus is co-administered with these drugs.

Drugs That May Affect Signs And Symptoms Of Hypoglycemia

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with Galactus.

Galactus side effects

See also:
What are the possible side effects of Galactus?

The following adverse reactions are discussed elsewhere:

• Hypoglycemia.
• Hypersensitivity and allergic reactions.
• Hypokalemia.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two clinical trials with Galactus were conducted: one in type 1 diabetes and one in type 2 diabetes.

The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes was 16 years. 58% were male. 75% were Caucasian, 2% Black or African American and 4% American Indian or Alaskan native. 4% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 73.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 26 kg/m². HbA1c at baseline was 7.8%. The data in Table 1 reflect exposure of 268 patients to Galactus with a mean exposure duration of 49 weeks.

The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 11 years. 50% were male. 78% were Caucasian, 8% Black or African American and 5% American Indian or Alaskan native. 28% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 67.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 32 kg/m². HbA1c at baseline was 8.3%. The data in Table 2 reflect exposure of 376 patients to Galactus with a mean exposure duration of 22 weeks.

Common adverse reactions were defined as reactions occurring in ≥ 5% of the population studied. Common adverse reactions during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

Table 1: Adverse reactions occurring in ≥ 5% of adult patients with type 1 diabetes treated with Galactus in a 52-week trial

	Galactus + Insulin Lispro, % (n=268)
Infection Infections other than nasopharyngitis or upper respiratory tract infection.

The frequencies of adverse reactions during a clinical trial of 5 years duration with another Galactus product, 100 units/mL, in patients with type 2 diabetes mellitus are listed in Table 3.

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥ 10% and higher with another Galactus product, 100 units/mL, than comparator)

	Another Galactus Product, % (n=514)	NPH, % (n=503)
Hypertension	20	19
Sinusitis	19	18
Cataract	18	16
Bronchitis	15	14
Back pain	13	12
Cough	12	7
Urinary tract infection	11	10
Diarrhea	11	10
Depression	11	10
Headache	10	9

The frequencies of adverse reactions during clinical trials with another Galactus product, 100 units/mL, in children and adolescents with type 1 diabetes mellitus are listed in Table 4.

Table 4: Adverse reactions in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with frequency ≥ 5% and the same or higher with another Galactus product, 100 units/mL, than comparator)

	Another Galactus Product, % (n=174)	NPH, % (n=175)
Rhinitis	5	5

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Galactus. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for Galactus with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.

Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL ( ≤ 56 mg/dL in the 5-year trial and ≤ 36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

The incidence of severe symptomatic hypoglycemia in patients receiving Galactus with type 1 diabetes mellitus and type 2 diabetes mellitus was 4% at 52 weeks and 1% at 24 weeks, respectively.

The incidence of severe symptomatic hypoglycemia in a clinical trial with another Galactus product, 100 units/mL, in children and adolescents age 6 to 15 years with type 1 diabetes was 23% at 26 weeks.

Table 5 displays the proportion of patients experiencing severe symptomatic hypoglycemia in another Galactus product, 100 units/mL, and Standard Care groups in the ORIGIN Trial.

Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial

	ORIGIN Trial Median duration of follow-up: 6.2 years
Another Galactus Product, 100 units/mL (N=6231)	Standard Care (N=6273)
Percent of patients	6	2

Allergic Reactions

Some patients taking insulin therapy, including Galactus have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported.

Peripheral Edema

Some patients taking Galactus have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including Galactus, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.

Weight Gain

Weight gain has occurred with some insulin therapies including Galactus and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity.

In a 52-week study of type 1 diabetes patients, 42% of patients who received Galactus once daily were positive for anti-drug antibodies (ADA) at least once during the study, including 17% that were positive at baseline and 25% of patients who developed ADA during the study. Sixty-five percent of the ADA positive patients on Galactus with antibody testing at week 52 remained ADA positive at week 52.

In a 24-week study of type 2 diabetes patients, 17% of patients who received Galactus once daily were positive for ADA at least once during the study. Among the subjects who were positive, 5% had ADA at baseline and 12% developed antibodies during the study. The percent binding of patients positive at baseline on Galactus did not increase significantly during the study. Fifty-one percent of the ADA positive patients on Galactus with antibody testing at week 24 remained ADA positive at week 24. There was no evidence that these antibodies had an impact on efficacy and safety outcomes.

The detection of antibody formation is highly 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 medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to Galactus with the incidence of antibodies in other studies or to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of another Galactus product, 100 units/mL. 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 insulin products, particularly rapid-acting insulins, have been accidentally administered instead of an Galactus product. To avoid medication errors between Galactus products and other insulin products, patients should be instructed to always verify the insulin label before each injection.

Galactus contraindications

See also:
What is the most important information I should know about Galactus?

Galactus injection is contraindicated:

•

during episodes of hypoglycemia.

•

in patients with hypersensitivity to Galactus products or any of the excipients in Galactus injection.

Active ingredient matches for Galactus:

Insulin Glargine in Mexico.

List of Galactus substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Chang Xiu Lin (China)
GLARGINE 100IU/ML INJECTION
GLARGINE 100IU/ML INJECTION 1 vial / 3 ML injection each (Jan Aushadhi)	$ 7.12
Glarin (Turkey)
Glarine (Bangladesh)
Glaritus (Thailand)
Glaritus 100 IU x 1 tube 3 mL (Ambica)
GLARITUS 100IU CARTRIDGE 1 packet / 3 ML cartridge each (Ambica)	$ 5.75
GLARITUS 100IU DISPOSABLE PEN 1 packet / 3 ML disposable pen each (Ambica)	$ 7.72
GLARITUS 100IU INJECTION 1 vial / 10 ML injection each (Ambica)	$ 15.83
GLARITUS 40IU INJECTION 1 vial / 10 ML injection each (Ambica)	$ 13.77
GLARITUS inj 100 IU x 3ml (Ambica)	$ 5.24
Glaritus 100IU Cartridge (Ambica)	$ 6.30
Glaritus 100IU Disposable Pen (Ambica)	$ 2.82
Glaritus 100IU Injection (Ambica)	$ 1.73
Glaritus 40IU Injection (Ambica)	$ 1.38
GLARITUS DISPOPEN (India)
GLARITUS DISPOPEN inj 100 IU x 3ml (Wockhardt (SSD))	$ 7.04
GLARVIA (India)
GLARVIA inj 100 IU x 1 mL x 3ml (Pfizer)	$ 5.72
Insulin Glargine BS (Japan)
Insulin Glargine Cartridge Systems
Insulin Optisulin (Luxembourg)
Insulina Basaglar (Argentina)
Insulina Glargina Elite Medical (Mexico)
Insulina Optisulin (Argentina)
Insuline Lantus
Injectable; Injection; Insulin Glargine 100 IU / ml
Insuline Lantus Opticlik
Injectable; Injection; Insulin Glargine 100 IU / ml
Insuline Lantus Optiset
Injectable; Injection; Insulin Glargine 100 IU / ml
Insuline Lantus Solostar
Injectable; Injection; Insulin Glargine 100 IU / ml
Lantaus (Bangladesh)
Lantus 100 egység/ml (Hungary)
Lantus 100 Einheiten/ml (Austria)
Lantus 100E/ml (Oman, Switzerland)
LANTUS AUTOPEN (India)
100 IU x 1 mL x 1's (Aventis Pasteur)	$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml (Aventis Pasteur)	$ 28.92
LANTUS AUTOPEN inj 100 IU x 1 mL x 3ml (Aventis Pasteur)	$ 28.92
Lantus Autopen 10 IU x 1mL INJ / 3ml (Aventis Pasteur)	$ 28.92
LANTUS CARTRIDGE (India)
100 IU x 1 mL x 3ml (Aventis Pasteur)	$ 5.82
Lantus Cartridge 100 IU x 1mL INJ / 3ml (Aventis Pasteur)	$ 5.82
LANTUS CARTRIDGE inj 100 IU x 1 mL x 3ml (Aventis Pasteur)	$ 5.82
Lantus Cartridge 100 IU x 1mL INJ / 3ml (Aventis Pasteur)	$ 5.82
Lantus Cartridge Systems
Lantus OptiClik Cartridge
Lantus OptiSet (Romania)
Injectable; Injection; Insulin Glargine 100 IU / ml (Sanofi - aventis)
Lantus Solo Star (Denmark)
See 97 substitutes for Galactus

References

1. PubChem. "Insulin glargine". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
2. DrugBank. "Insulin Glargine - DrugBank". http://www.drugbank.ca/drugs/DB00047 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Galactus are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Galactus. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology