Octagam 30mg/300ml Inj 300ml

Manufacturer OCTAPHARMA USA Active Ingredient Immune Globulin (IV)(i MYUN GLOB yoo lin) Pronunciation OK-tuh-gam (for Octagam); ih-MYUN GLOB-yoo-lin (for Immune Globulin)
WARNING: There is a chance of blood clots with this drug. The chance is raised in older people and in people with thick blood, heart problems, or a history of blood clots. The chance may also be higher if you must be in a bed or chair for some time, if you take estrogen, or if you use certain catheters. However, blood clots can happen even if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug. @ COMMON USES: It is used to help prevent infections or make infections less severe in people with a weak immune system.It is used to treat immune thrombocytopenia (ITP).It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).It is used to treat Kawasaki disease.It is used to treat a certain muscle problem caused by inflammation (dermatomyositis).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Immunoglobulin
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Pharmacologic Class
Blood product; Immune globulin
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Pregnancy Category
Category C
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FDA Approved
Aug 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Octagam is a medicine made from human blood plasma that contains antibodies. Antibodies are proteins that help your body fight off infections and diseases. It's given directly into your vein (intravenously) to help boost your immune system or to calm down an overactive immune system, depending on your condition.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Stay well-hydrated before, during, and after your infusion, as directed by your healthcare provider.
  • Report any unusual symptoms immediately during or after the infusion, such as headache, fever, chills, rash, difficulty breathing, chest pain, or swelling/pain in your arms or legs.
  • Avoid live virus vaccines (like MMR, chickenpox) for at least 3 months after receiving Octagam, as the antibodies can make the vaccine less effective. Discuss your vaccination schedule with your doctor.
  • Follow all instructions regarding infusion rate and duration. Do not adjust the rate yourself.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Examples: Primary Immunodeficiency (PI): 300-800 mg/kg every 3-4 weeks. Idiopathic Thrombocytopenic Purpura (ITP): 1 g/kg daily for 1-2 days or 400 mg/kg daily for 2-5 days. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading dose 2 g/kg over 2-5 days, then maintenance 1 g/kg every 3 weeks or 0.5 g/kg every week.
Dose Range: 300 - 2000 mg

Condition-Specific Dosing:

Primary Immunodeficiency (PI): 300-800 mg/kg every 3-4 weeks
Idiopathic Thrombocytopenic Purpura (ITP): 1 g/kg daily for 1-2 days or 400 mg/kg daily for 2-5 days
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Loading: 2 g/kg over 2-5 days; Maintenance: 1 g/kg every 3 weeks or 0.5 g/kg weekly
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Pediatric Dosing

Neonatal: Dosing is weight-based and indication-specific. Caution with fluid overload and renal function. For PI, similar mg/kg dosing as adults. For Kawasaki Disease: 2 g/kg as a single infusion.
Infant: Dosing is weight-based and indication-specific. For PI, similar mg/kg dosing as adults. For Kawasaki Disease: 2 g/kg as a single infusion.
Child: Dosing is weight-based and indication-specific. For PI, similar mg/kg dosing as adults. For Kawasaki Disease: 2 g/kg as a single infusion.
Adolescent: Dosing is weight-based and indication-specific. For PI, similar mg/kg dosing as adults. For Kawasaki Disease: 2 g/kg as a single infusion.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor renal function and hydration status. Administer at the minimum concentration and infusion rate practicable.
Moderate: No specific dose adjustment, but monitor renal function and hydration status closely. Administer at the minimum concentration and infusion rate practicable.
Severe: No specific dose adjustment, but monitor renal function and hydration status closely. Administer at the minimum concentration and infusion rate practicable. Consider alternative therapies or lower doses/slower rates in patients at risk for acute renal failure.
Dialysis: Not specifically studied. Use with caution and close monitoring of renal function and fluid balance. Octagam is sucrose-free, which may reduce risk compared to sucrose-containing IVIGs.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.

Pharmacology

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Mechanism of Action

Immune Globulin Intravenous (Human) (IVIG) provides broad-spectrum immunomodulatory effects. It contains a wide range of antibodies against various infectious agents and toxins. The precise mechanisms of action in various conditions are not fully elucidated but include: modulation of Fc receptors, interference with complement activation, suppression of autoantibody production, neutralization of pathogenic antibodies, and anti-inflammatory effects through various cytokine and cellular pathways.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: End of infusion
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.07 L/kg (initially intravascular, then equilibrates with extravascular space)
ProteinBinding: Not applicable (is a protein)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 21-35 days (variable depending on patient's underlying condition and IgG catabolism rate)
Clearance: Variable, depends on IgG catabolism rate
ExcretionRoute: Not applicable (catabolized)
Unchanged: Not applicable (catabolized)
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Pharmacodynamics

OnsetOfAction: Hours to days (e.g., platelet count increase in ITP within 24-48 hours; clinical improvement in PI over days to weeks)
PeakEffect: Days to weeks (e.g., peak platelet count in ITP within 2-7 days; steady-state IgG levels in PI after several doses)
DurationOfAction: Weeks to months (e.g., 3-4 weeks for PI; variable for other indications)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

THROMBOSIS may occur with immune globulin products, including Octagam. Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, and cardiovascular risk factors. For patients at risk of thrombosis, administer Octagam at the minimum concentration available and the minimum infusion rate practicable. Ensure adequate hydration in patients prior to administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Seizures
Bloating
Confusion
Swelling
Abnormal heartbeat
Mood changes
Muscle or joint pain
Changes in speech or eyesight
Shakiness
Excessive sweating
Severe stomach pain
Dark urine or yellow skin and eyes

Severe Lung Problems and Aseptic Meningitis

This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Trouble breathing
Shortness of breath
New or worsening cough

Additionally, this medication may increase the risk of aseptic meningitis, a severe brain problem. If you experience any of the following symptoms, contact your doctor immediately:
Headache
Fever
Chills
Nausea or vomiting
Stiff neck
Rash
Sensitivity to light
Feeling sleepy or confused

Immune Globulin Therapy and Dehydration

If you are receiving immune globulin therapy for the first time, have not had it in the past 8 weeks, or are switching brands, you may be at risk for certain side effects, including:
Fever
Chills
Nausea
Vomiting

Dehydration and low sodium levels can also occur when this medication is given intravenously. If you experience any of the following symptoms, contact your doctor right away:
Dry skin, mouth, or eyes
Thirst
Fast heartbeat
Dizziness
Fast breathing
Confusion
Headache
Trouble focusing
Memory problems
Feeling confused
Weakness
Seizures
Changes in balance

Other Side Effects

While many people do not experience side effects or only have minor ones, it is essential to contact your doctor or seek medical attention if you experience any of the following:
Irritation at the injection site
Dizziness, tiredness, or weakness
Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Back pain
Muscle spasm
Signs of a common cold
Flushing
* Cramps

If you have any questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe headache, neck stiffness, sensitivity to light, nausea, vomiting (signs of aseptic meningitis)
  • Sudden decrease in urine output, swelling in legs/feet, unusual fatigue (signs of kidney problems)
  • Sudden chest pain, shortness of breath, pain/swelling/redness in an arm or leg, vision changes, weakness or numbness on one side of the body (signs of a blood clot)
  • Hives, rash, itching, swelling of face/lips/tongue/throat, wheezing, difficulty breathing, dizziness, fainting (signs of a severe allergic reaction)
  • Fever, chills, muscle aches, back pain (common infusion-related reactions, but report them)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced.
If you have IgA deficiency, a condition where your body lacks a specific antibody.
If you have hyperprolinemia, a condition characterized by elevated levels of proline in your blood.
If you have excess fluid in your body or have been advised to monitor your fluid intake.
If you are unable to break down fructose, a type of sugar. Some formulations of this medication may contain sorbitol, which can be problematic for individuals with this condition.

Special Considerations for Children:

If your child is an infant or baby, and it is unclear whether they can break down sucrose or fructose, do not administer this medication without consulting your doctor.

Additional Important Information:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, be sure to discuss this with your doctor.

Before receiving any vaccines, consult with your doctor, as the use of certain vaccines in combination with this medication may increase the risk of infection or reduce the vaccine's effectiveness.

Regularly undergo blood tests and other laboratory examinations as directed by your doctor. This medication may interfere with the results of certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.

If you have a weakened immune system and have been exposed to measles, consult with your doctor. This medication is derived from human plasma and, although it is thoroughly screened, tested, and treated to minimize the risk of infection, it may still pose a risk of transmitting viruses. Discuss this with your doctor.

If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.

If you have diabetes (high blood sugar), consult with your doctor to determine the most suitable glucose tests to use.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fluid overload (e.g., shortness of breath, swelling)
  • Increased blood viscosity
  • Acute renal failure (in susceptible patients)

What to Do:

Discontinue infusion immediately. Manage symptoms supportively. May require diuretics for fluid overload or dialysis for severe renal impairment. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Live virus vaccines (e.g., measles, mumps, rubella, varicella): Antibodies in IVIG may interfere with the immune response to live virus vaccines. Vaccination should be deferred for at least 3 months after IVIG administration. If vaccination is necessary, antibody titers should be checked after vaccination to ensure adequate immune response.
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Moderate Interactions

  • Loop diuretics: Concomitant use may increase the risk of acute renal failure, especially in patients with pre-existing renal impairment or risk factors. Monitor renal function closely.
  • Nephrotoxic drugs: Increased risk of renal dysfunction when co-administered with other nephrotoxic agents. Monitor renal function.

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: To identify pre-existing renal impairment and establish baseline for monitoring potential acute renal failure.

Timing: Prior to initiation of therapy

Hydration status

Rationale: To ensure adequate hydration before infusion, reducing risk of renal adverse events.

Timing: Prior to and during infusion

Vital signs (blood pressure, heart rate, temperature)

Rationale: To establish baseline and detect immediate infusion-related reactions.

Timing: Prior to infusion

Serum IgA levels

Rationale: To screen for IgA deficiency, which increases risk of anaphylactic reactions in patients with anti-IgA antibodies.

Timing: Prior to first infusion (if not previously known)

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Routine Monitoring

Vital signs (blood pressure, heart rate, temperature)

Frequency: Every 15-30 minutes during infusion, then hourly for 1 hour post-infusion

Target: Within patient's normal limits

Action Threshold: Significant changes (e.g., hypotension, tachycardia, fever) warrant slowing/stopping infusion and intervention.

Signs and symptoms of adverse reactions (e.g., headache, chills, fever, rash, dyspnea, chest pain, back pain)

Frequency: Continuously during and for several hours post-infusion

Target: Absence of symptoms

Action Threshold: Presence of symptoms warrants slowing/stopping infusion and symptomatic treatment.

Urine output and fluid balance

Frequency: During and after infusion, especially in at-risk patients

Target: Adequate urine output

Action Threshold: Decreased urine output or signs of fluid overload warrant intervention.

Renal function (BUN, serum creatinine)

Frequency: Within 24-48 hours post-infusion, especially in at-risk patients (e.g., pre-existing renal impairment, diabetes, elderly, volume depletion, concomitant nephrotoxic drugs)

Target: Within baseline limits

Action Threshold: Significant increase (e.g., >0.5 mg/dL or >50% from baseline) warrants investigation and potential discontinuation.

Signs/symptoms of thrombosis (e.g., pain, swelling, discoloration of limb, shortness of breath, chest pain)

Frequency: During and for several days/weeks post-infusion

Target: Absence of symptoms

Action Threshold: Presence of symptoms warrants immediate medical evaluation.

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Symptom Monitoring

  • Headache
  • Chills
  • Fever
  • Nausea
  • Vomiting
  • Fatigue
  • Dizziness
  • Rash
  • Hives
  • Dyspnea
  • Chest tightness
  • Back pain
  • Muscle cramps
  • Signs of allergic reaction (wheezing, swelling of face/throat)
  • Signs of aseptic meningitis (severe headache, nuchal rigidity, photophobia, fever, nausea, vomiting)
  • Signs of renal dysfunction (decreased urine output, swelling, fatigue)
  • Signs of thrombosis (pain, swelling, warmth, redness in limb; sudden shortness of breath, chest pain, vision changes, weakness/numbness on one side of body)

Special Patient Groups

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Pregnancy

Octagam is classified as Pregnancy Category C. Animal reproduction studies have not been conducted. However, immune globulins are known to cross the placental barrier, particularly in the third trimester. Clinical experience with IVIG in pregnant women suggests no adverse effects on the course of pregnancy, fetus, or neonate. Use only if clearly needed and potential benefits outweigh potential risks.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk as IgG transfer is minimal in early pregnancy.
Second Trimester: Limited data, but generally considered low risk.
Third Trimester: Significant placental transfer of IgG occurs, potentially affecting the neonate's immune response to live vaccines. No known direct teratogenic effects.
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Lactation

Immune globulins are naturally present in human milk. While there are no specific studies on Octagam in lactating women, the transfer of intact antibodies into breast milk is minimal, and absorption by the infant is unlikely. Therefore, breastfeeding is generally considered safe and beneficial for the infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Octagam and any potential adverse effects on the breastfed child from Octagam or from the underlying maternal condition.

Infant Risk: L2 (Safer - Limited data, no adverse effects reported)
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Pediatric Use

Dosing is weight-based and indication-specific. Octagam has been studied and approved for use in pediatric patients for various indications (e.g., PI, ITP, CIDP, Kawasaki Disease). Caution should be exercised in neonates and infants due to potential for fluid overload and immature renal function. Monitor vital signs and renal function closely.

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Geriatric Use

Use with caution in elderly patients, especially those with pre-existing renal impairment, diabetes mellitus, or cardiovascular disease, due to increased risk of acute renal failure and thrombotic events. Administer at the minimum concentration and infusion rate practicable. Ensure adequate hydration.

Clinical Information

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Clinical Pearls

  • Always ensure adequate hydration before, during, and after IVIG infusion to minimize the risk of renal adverse events.
  • Infuse slowly initially and gradually increase the rate if tolerated, especially for the first infusion or in patients at high risk for adverse reactions.
  • Pre-medication (e.g., antihistamines, acetaminophen, corticosteroids) may be considered for patients with a history of infusion-related reactions, but is not routinely required for all patients.
  • Octagam is sucrose-free, which may be advantageous for patients at risk for sucrose-induced osmotic nephropathy, but renal monitoring is still crucial.
  • Patients with IgA deficiency and known anti-IgA antibodies are at increased risk of severe allergic reactions, including anaphylaxis. Octagam contains trace amounts of IgA. These patients should be monitored closely, and alternative treatments considered if severe reactions occur.
  • Educate patients about the signs and symptoms of thrombosis and renal dysfunction, and advise them to seek immediate medical attention if these occur.
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Alternative Therapies

  • Other IVIG products (e.g., Gammagard S/D, Gamunex-C, Privigen, Flebogamma DIF)
  • Subcutaneous Immune Globulin (SCIG) products (e.g., Hizentra, Gammaked, Cuvitru, Xembify) for primary immunodeficiency
  • Corticosteroids (e.g., prednisone, dexamethasone) for autoimmune conditions like ITP or CIDP
  • Immunosuppressants (e.g., azathioprine, mycophenolate mofetil, rituximab) for various autoimmune disorders
  • Plasma exchange (plasmapheresis) for certain neurological or autoimmune conditions
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Cost & Coverage

Average Cost: Highly variable, typically several thousand to tens of thousands of dollars per infusion depending on dose and patient weight. per 30g/300ml vial (approximate)
Insurance Coverage: Specialty Tier / Medical Benefit (often covered under medical benefit for specific indications)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication that has been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best method for disposal, as some communities have drug take-back programs in place.

Additionally, some medications may come with a separate patient information leaflet; if you have questions, consult with your pharmacist. If you have any concerns or questions about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid healthcare professionals in providing appropriate treatment.