Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose

FDA Drug Information • Also known as: Clinimix

Brand Names: Clinimix
Drug Class: Amino Acid [EPC]
Route: INTRAVENOUS
Dosage Form: INJECTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8 . Table 8: Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH The injection port chamber contains dextrose. Dextrose, USP, is chemically designated D-glucose, monohydrate (C 6 H 12 O 6

H 2 O) and has the following structure: Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [ see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX contains no more than 25 mcg/L of aluminum. Structural Formula Dexrose Hydrous, USP

What Is Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose Used For?

1 INDICATIONS AND USAGE CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 Preparation Prior to Administration

CLINIMIX is available in a three port container configuration and a two port container configuration. o Three Port Container : the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. o Two Port Container : the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container.

Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.

Inspect the container prior to activation. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow. Discard if the seal is broken or if the solution is bright yellow or yellowish brown. o Check for minute leaks by separately squeezing each chamber. If external leaks or leakage between the chambers are found, discard solution as sterility or stability may be impaired.

Lipids and/or additives can be introduced to the container after opening seal between chambers. Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced. Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.

Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1) ] .

Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product. If lipid has been...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ]

Hypersensitivity reactions [see Warnings and Precautions (5.2) ]

Risk of Infections [see Warnings and Precautions (5.3) ]

Refeeding syndrome [see Warnings and Precautions (5.4) ]

Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ]

Vein damage and thrombosis [see Warnings and Precautions (5.6) ]

Hepatobiliary disorders [see Warnings and Precautions (5.7) ]

Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ]

Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Diuresis

Extravasation

Glycosuria

Hyperglycemia

Hyperosmolar coma Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Contraindications

4 CONTRAINDICATIONS The use of CLINIMIX is contraindicated in:

Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2) ] .

Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications.

Patients with pulmonary edema or acidosis due to low cardiac output.

Known hypersensitivity to one or more amino acids or dextrose. ( 4)

Inborn errors of amino acid metabolism. ( 4 )

Patients with pulmonary edema or acidosis due to low cardiac output. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.

Overdosage

10 OVERDOSAGE An increased infusion rate of CLINIMIX cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.5 , 5.10) ]. Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems . For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING CLINIMIX (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Table 9: CLINIMIX Formulations (per 07-19-00-3604 and BE-30-03-648) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection Code 2B7726 NDC 0338‑1133‑03 Code 2B7704 NDC 0338‑1089‑04 CLINIMIX 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection Code 2B7727 NDC 0338‑1134‑03 Code 2B7705 NDC 0338‑1091‑04 CLINIMIX 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection Code 2B7730 NDC 0338‑1137‑03 Code 2B7709 NDC 0338‑1099‑04 CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection Code 2B7731 NDC 0338‑1138‑03 Code 2B7710 NDC 0338‑1101‑04 CLINIMIX 6/5 sulfite‑free (6% Amino Acid in 5% Dextrose) Injection Code EADB9913 NDC 0338‑0198-06 _____ CLINIMIX 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection Code EADB9933 NDC 0338‑0188-06 Code EADB9935 NDC 0338‑0194-04 CLINIMIX 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection Code EADB9953 NDC 0338‑0180-06 Code EADB9955 NDC 0338‑0184-04 Table 9: CLINIMIX Formulations (per BE-30-04-047) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection Code 2B7726L NDC 0338‑7001-01 Code 2B7704L NDC 0338‑7003-01 CLINIMIX 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection Code 2B7727L NDC 0338‑7005-01 Code 2B7705L NDC 0338‑7007-01 CLINIMIX 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection Code 2B7730L NDC 0338‑7009-01 Code 2B7709L NDC 0338‑7011-01 CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection Code 2B7731L NDC 0338‑7013-01 Code 2B7710L NDC 0338‑7015-01 CLINIMIX 6/5 sulfite‑free (6% Amino Acid in 5% Dextrose) Injection Code EADB9913 NDC 0338‑0198-06 _____ CLINIMIX 8/10...

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.