Avita


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Related to Avita: AVISTA, Evita

treprostinil sodium

Remodulin, TyvasoAtralin, Avita, Renova, Retin-A, Retin-A Micro, VesanoidAdcortyl (UK), Kenalog, Kenalog-10, Kenalog-40, Nasacort AQ, Triaderm (CA)

Pharmacologic class: Synthetic prostacyclin analog

Therapeutic class: Antiplatelet agent, vasodilator

Pregnancy risk category B

Pharmacologic class: Retinoid

Therapeutic class: Antineoplastic, dermatologic agent (topical)

Pregnancy risk category C (topical), D (oral)

Pregnancy risk category C (topical), D (oral)

FDA Box Warning

• Patients with acute promyelocytic leukemia (APL) are at high risk in general and may have severe adverse reactions. Give drug under supervision of physician experienced in managing patients with acute leukemia, in facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain patient compromised by drug toxicity.

• Before using drug, physician must conclude that possible benefit to patient outweighs the following known adverse effects:

• Retinoic acid-APL (RA-APL syndrome), which may be accompanied by impaired myocardial contractility, hypotension, and progressive hypoxemia. Several patients have died with multiorgan failure. Syndrome generally occurs during first month of therapy (in some cases, after first dose).

• Leukocytosis at presentation or evolving rapidly during drug therapy. Patients with high white blood cell (WBC) at diagnosis (above 5 × 109/L) have increased risk of further rapid rise in WBC counts. Rapidly evolving leukocytosis raises risk of life-threatening complications.

• Teratogenic effects. Drug therapy during pregnancy carries high risk of severe birth defects. Nonetheless, if drug is best available treatment for pregnant woman or woman of childbearing potential, ensure that she has received full information and warnings of risk to fetus and of risk of possible contraception failure, and has been taught to use two reliable contraceptive methods simultaneously during therapy and for 1 month afterward.

Action

Dilates pulmonary and systemic arterial vascular beds, reducing right and left ventricular afterload and increasing cardiac output and stroke volume. Also inhibits platelet aggregation.

Availability

Injection: 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml

Solution for oral inhalation: 2.9-ml ampule containing 1.74 mg treprostinil (0.6 mg/ml)

Indications and dosages

To diminish exercise-induced symptoms of pulmonary artery hypertension (PAH) in patients with NYHA class II-IV symptoms

Adults: Initially, 1.25 ng/kg/minute by continuous subcutaneous infusion; if initial dose isn't tolerated, reduce infusion rate to 0.625 ng/kg/minute. For maintenance, may increase infusion rate in increments of no more than 1.25 ng/kg/minute q week for first 4 weeks, then in increments of no more than 2.5 ng/kg/minute q week, if needed. Maximum dosage is 40 ng/kg/minute.

To treat pulmonary arterial hypertension (PAH) WHO Group 1 to improve exercise ability

Adults: Initially, 3 breaths (18 mcg) oral inhalation solution per treatment session q.i.d. If 3 breaths aren't tolerated, reduce to 1 or 2 breaths and subsequently increase to 3 breaths, as tolerated. For maintenance, increase dose by an additional 3 breaths at approximately 1- to 2-week intervals, if tolerated, until target dose of 9 breaths (54 mcg) is reached per treatment session q.i.d. If adverse effects preclude titration to target dose, continue at highest tolerated dose. If scheduled treatment session is missed or interrupted, resume therapy as soon as possible at usual dose. Maximum recommended dosage is 9 breaths per treatment session q.i.d.

Dosage adjustment

• Hepatic insufficiency
• Concurrent use of CYP2C8 inhibitors or inducers

Contraindications

None

Precautions

Use cautiously in:
• renal disease
• history of hepatic disease
• significant underlying lung disease such as asthma or chronic obstructive pulmonary disease (Tyvaso)
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

Give first continuous subcutaneous infusion dose in setting where resuscitation equipment is available and other health care personnel can assist if an emergency arises.
• Administer by continuous subcutaneous infusion through subcutaneous catheter with infusion pump made specifically for subcutaneous infusions.
• Expect to adjust continuous subcutaneous infusion dosage for first 6 to 12 weeks as prescriber balances symptom improvement against adverse reactions.

Don't stop infusion abruptly (may worsen PAH).
• Use oral inhalation solution only with inhalation system provided.
• Don't mix oral inhalation solution with other drugs.
• Space oral inhalation solution treatment sessions equally during waking hours, approximately 4 hours apart.

Adverse reactions

CNS: dizziness, headache, anxiety, restlessness

CV: vasodilation, edema, hypotension, syncope

EENT: jaw pain, throat irritation, pharyngolaryngeal pain (inhalation solution)

Hematologic: bleeding

Respiratory: cough (inhalation solution)

GI: nausea, vomiting, diarrhea

Skin: rash, pruritus, flushing

Other: infusion site pain or reaction (such as erythema, rash, induration), possible fatal bloodstream infections and sepsis (subcutaneous infusion)

Interactions

Drug-drug.Anticoagulants: increased risk of bleeding

Antihypertensives, diuretics, other vasodilators: increased risk of hypotension

CYP2C8 inhibitors (such as gemfibrozil) or inducers (such as rifampin): decreased treprostinil exposure

Vitamin A: increased risk of bleeding

Drug-herbs.Alfalfa, anise, arnica, astragalus, bilberry, black currant seed oil, bladderwrack, bogbean, boldo (with fenugreek), borage oil, buchu, capsaicin, cat's claw, celery, chaparral, chincona bark, clove oil, dandelion, dong quai, evening primrose oil, fenugreek, feverfew, garlic, ginger, ginkgo, guggul, papaya extract, red clover, rhubarb, safflower oil, skullcap, tan-shen: increased risk of bleeding

Patient monitoring

Especially after first dose, watch closely for severe vasodilation leading to chest pain and hypotension. These signs and symptoms call for emergency measures.

Monitor vital signs. Assess carefully for indications of right ventricular failure.
• Assess neurologic status. Institute safety measures as needed to prevent injury.

Watch for infusion site reaction; be aware that route is associated with risk of bloodstream infections and sepsis, which may be fatal.

Patient teaching

• Tell patient continuous subcutaneous infusion is a long-term measure to control PAH and requires a commitment to maintain infusion system.
• Tell patient to follow instructions for operation of inhalation system and for daily cleaning of device components after last treatment session of day.
• Tell patient not to swallow and to avoid skin or eye contact with oral inhalation solution.

Instruct patient to immediately report signs and symptoms of infusion site reaction (such as redness, rash, and hardened tissue).
• Teach patient which symptoms reflect underlying disease and which may reflect adverse reactions that he should report.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and herbs mentioned above.


tretinoin

Atralin, Avita, Renova, Retin-A, Retin-A Micro, Vesanoid


Pharmacologic class: Retinoid

Therapeutic class: Antineoplastic, dermatologic agent (topical)

Pregnancy risk category C (topical), D (oral)

 

FDABOXED WARNING

• Patients with acute promyelocytic leukemia (APL) are at high risk in general and may have severe adverse reactions. Give drug under supervision of physician experienced in managing patients with acute leukemia, in facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain patient compromised by drug toxicity.

• Before using drug, physician must conclude that possible benefit to patient outweighs the following known adverse effects:

• Retinoic acid-APL (RA-APL syndrome), which may be accompanied by impaired myocardial contractility, hypotension, and progressive hypoxemia. Several patients have died with multiorgan failure. Syndrome generally occurs during first month of therapy (in some cases, after first dose).

• Leukocytosis at presentation or evolving rapidly during drug therapy. Patients with high white blood cell (WBC) at diagnosis (above 5 × 109/L) have increased risk of further rapid rise in WBC counts. Rapidly evolving leukocytosis raises risk of life-threatening complications.

• Teratogenic effects. Drug therapy during pregnancy carries high risk of severe birth defects. Nonetheless, if drug is best available treatment for pregnant woman or woman of childbearing potential, ensure that she has received full information and warnings of risk to fetus and of risk of possible contraception failure, and has been taught to use two reliable contraceptive methods simultaneously during therapy and for 1 month afterward.

Action

Unknown. Thought to cause differentiation of promyelocytic leukemic blast cells, leading to apoptosis (cell shrinkage and death) and cancer remission.

Availability

Capsules: 10 mg

Topical cream: 0.02%, 0.025%, 0.05%, 0.1%

Topical gel: 0.01%, 0.025%, 0.04%, 0.1%

Indications and dosages

APL when anthracycline chemotherapy fails or is contraindicated

Adults and children ages 1 and older: 45 mg/m2/day P.O. in two evenly divided doses. Discontinue after 90 days of therapy or 30 days after complete remission occurs, whichever comes first.

Acne vulgaris

Adults: Apply Avita cream, Retin-A cream gel, or Retin-A Micro gel daily before bedtime or in evening. Cover entire affected area lightly.

Adjunct for mitigating fine wrinkles in patients who use comprehensive skin care and sun avoidance programs

Adults: Apply Renova 0.02% cream to face daily in evening for up to 52 weeks, using only enough to lightly cover entire affected area.

Adjunct for mitigating fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin when comprehensive skin care and sun avoidance programs alone fail

Adults ages 50 and younger: Apply Renova 0.05% cream to face daily in evening for up to 48 weeks, using only enough to lightly cover entire affected area.

Contraindications

• Hypersensitivity to drug or parabens
• Pregnancy or breastfeeding (oral use)

Precautions

Use cautiously in:
• eczema, sunburn, photosensitivity
• concurrent use of over-the-counter (OTC) acne products or abrasive soaps or cleansers with strong drying effects or high alcohol or lime content (with all topical forms)
• concurrent use of astringents, spices, permanent wave solutions, electrolysis, hair depilatories or waxes, or photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides)
• heavily pigmented, elderly, pregnant, or breastfeeding patients (safety and efficacy not established for topical use)
• children younger than age 1 for oral use or younger than age 18 for topical use (safety and efficacy not established).

Administration

• Verify that female patient has had required pregnancy test before P.O. therapy starts.
• Know that Renova topical cream isn't indicated for acne vulgaris, and that other topical forms are indicated only for acne vulgaris. Also know that some absorption of topical products occurs.

Adverse reactions

CNS: dizziness, headache, asthenia, paresthesia, confusion, agitation, hallucinations, anxiety, aphasia, depression, agnosia, insomnia, asterixis, cerebellar edema, hypotaxia, drowsiness, slow speech, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, dementia, spinal cord disorder, tremors, dysarthria, cerebrovascular accident (CVA), coma, seizures, intracranial hypertension, cerebral hemorrhage

CV: heart murmur, chest discomfort, peripheral edema, hypertension, hypotension, phlebitis, edema, enlarged heart, ischemia, arrhythmias, secondary cardiomyopathy, myocarditis, myocardial infarction (MI), heart failure, pericardial effusion, impaired myocardial contractility, progressive hypoxemia

EENT: vision disturbances, visual acuity changes, visual field defect, absence of light reflex, hearing loss, earache, full sensation in ears

GI: nausea, vomiting, constipation, diarrhea, abdominal pain and distention, GI disorders, mucositis, dyspepsia, ulcer, anorexia, GI hemorrhage

GU: dysuria, urinary frequency, enlarged prostate, renal insufficiency, renal tubular necrosis, acute renal failure

Hematologic: leukocytosis, disseminated intravascular coagulation (DIC), hemorrhage

Hepatic: ascites, hepatosplenomegaly, hepatitis

Metabolic: fluid imbalance, acidosis

Musculoskeletal: bone pain or inflammation, myalgia, flank pain

Respiratory: respiratory tract disorders, dyspnea, expiratory wheezing, crackles, pneumonia, laryngeal edema, pulmonary infiltrates, pleural effusion, bronchial asthma, pulmonary hypertension

Skin: rash; pallor; flushing; diaphoresis; alopecia; dry skin and mucous membranes; skin changes; pruritus; cellulitis; burning, erythema, peeling, and stinging (with topical use)

Other: weight changes, fever, lymphatic disorder, hypothermia, infections, facial edema, pain, RA-APL syndrome, multisystem failure, septicemia

Interactions

Drug-drug.Photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides): increased risk of photosensitivity reaction (with topical forms)

Drug-diagnostic tests.Cholesterol, triglycerides: increased levels

Drug-food.Any food: enhanced tretinoin absorption

Drug-behaviors.Sun exposure: increased risk of photosensitivity

Patient monitoring

Watch closely for septicemia, multisystem failure, and retinoic acid-APL syndrome (which causes pulmonary and pericardial effusion, fever, weight gain, and dyspnea).

Monitor for significant adverse CNS reactions, including seizures, CVA, and cerebral hemorrhage.

Monitor cardiovascular status. Stay alert for signs and symptoms of arrhythmias, MI, and heart failure.

Closely monitor liver and kidney function tests. Watch for evidence of hepatitis and renal failure.

Monitor coagulation studies. Watch closely for DIC and hemorrhage.
• Evaluate respiratory status. Stay alert for indications of pulmonary hypertension and respiratory insufficiency.
• Frequently assess lipid panel and CBC with white cell differential.

Patient teaching

• Instruct patient to take oral doses with food.

Teach patient to recognize and immediately report serious adverse reactions.
• Tell patient he will undergo regular blood testing during oral therapy.
• Instruct patient using topical form to gently wash face with mild soap, pat skin dry, and then wait 20 to 30 minutes before applying. Advise him to apply to face in evening, using only enough to cover entire affected area lightly and only for prescribed duration.
• Caution patient to avoid OTC acne drugs and extreme weather conditions (such as wind and cold). Urge him to adhere to prescribed skin care and sunlight avoidance programs when using topical form.
• Tell patient using topical form that transient burning, erythema, peeling, pruritus, and stinging may occur. Advise him to notify prescriber if these symptoms become severe.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.


triamcinolone acetonide

Adcortyl (UK), Kenalog, Kenalog-10, Kenalog-40, Nasacort AQ, Triaderm (CA)


tretinoin (topical)

(tret-i-noyn) ,

Atralin

(trade name),

Avita

(trade name),

Rejuva-A

(trade name),

Renova

(trade name),

Retin-A

(trade name),

Retin-A Micro

(trade name),

Stieva-A

(trade name),

Vitamin A Acid

(trade name)

Classification

Therapeutic: antiacne agents
Pharmacologic: retinoids
Pregnancy Category: C

Indications

Management of acne vulgaris.Decreased facial dermal effects of photoaging (used with sun avoidance; 0.05% water-in-oil cream formulation only).

Action

Decreases the formation of microcomedomes and stimulates turnover of follicular epithelium.

Therapeutic effects

Decreases acne formation with improved skin appearance.
Decreased skin roughness, hyperpigmentation, and wrinkling due to photoaging.

Pharmacokinetics

Absorption: Minimal systemic absorption occurs with limited surface-area application.
Distribution: Unknown.
Metabolism and Excretion: <5% of dose applied to skin is excreted in urine.
Half-life: Unknown.

Time/action profile (improved skin appearance)

ROUTEONSETPEAKDURATION
Topical (acne)2–3 wk6 wkunknown
Topical (photoaging)within 24 wkunknown2 mo†
†Following discontinuation.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to tretinoin or any components in the formulation; Known alcohol intolerance (gel and liquid only).
Use Cautiously in: Areas around the mouth, eyes, angles of the nose, or other mucous membranes; Obstetric / Lactation / Pediatric: Safety not established; Safety/effectiveness in patients ≥50 yr, with a history of skin cancer or with moderately pigmented skin or for >48 wk not established.

Adverse Reactions/Side Effects

Dermatologic

  • photosensitivity (most frequent)
  • redness
  • blistering
  • edema
  • crusting
  • hyperpigmentation
  • hypopigmentation

Interactions

Drug-Drug interaction

Concurrent use with keratolytic agents (benzoyl peroxide, salicylic acid, sulfur, or resorcinol) ↑ risk of excessive skin irritation.↑ risk of photosensitivity with other photosensitizing agents.Risk of irritation ↑ by other topical skin-care products (aftershave, cover-up, make-up, perfumes, colognes).↑ absorption of topical minoxidil.

Route/Dosage

Acne
Topical (Adults and Adolescents >12 yr) Apply once daily at bedtime.
Photoaging
Topical (Adults) Renova—Apply a thin film once daily at bedtime; if irritation occurs, lower concentration or less frequent application may be tried.

Availability (generic available)

Cream: 0.02%, 0.025%, 0.05%, 0.1%
Gel: 0.01%, 0.025%, 0.05%
Gel microsphere formulation: 0.04%, 0.1%
Liquid: 0.05% in 30-ml containers
In combination with: clindamycin (Ziana); mequinol (Solage); hydroquinone and fluocinolone (Tri–Luma). See combination drugs).

Nursing implications

Nursing assessment

  • Assess skin prior to and periodically during therapy. Note number and severity of cysts, degree of skin dryness, erythema, and itching. Response to frequency of application and dose concentration is variable and should be closely monitored. Transient worsening of acne may occur at initiation of therapy. This may be due to the effects of tretinoin on deep, previously undetected lesions and is not a reason to discontinue therapy.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Indications,  Side Effects)
Disturbed body image (Indications)

Implementation

  • Topical: Tretinoin should be applied once a day before bedtime. Cover the entire area lightly. Wash hands immediately after application.
  • Liquid: Apply with fingertip, gauze pad, or cotton swab. Do not saturate gauze pad or cotton swab to the extent that medication runs on to unaffected area.
  • Gel: Excessive application results in “pilling” of gel, which minimizes overapplication of tretinoin.
    • May induce severe local edema and peeling at the site of application. If this occurs, tretinoin may be used less frequently, or discontinued temporarily or completely.

Patient/Family Teaching

  • Instruct patient to apply tretinoin as directed. Application may cause a transient feeling of warmth and a slight stinging. Avoid application near eyes, mouth, angle of the nose, and mucous membranes. Do not apply excessive amounts, because this may cause redness, peeling, or discomfort and will not improve results. If a dose is missed, omit and apply next dose at regularly scheduled time; do not double doses.
  • Explain to patient that a temporary worsening of acne may occur at beginning of therapy.
  • Advise patient to consult with health care professional before using other acne preparations while using tretinoin. Normal use of cosmetics is permissible, but area to be treated must be thoroughly cleansed prior to application. Medicated or abrasive soaps or cleansers, soaps and cosmetics that have a strong drying effect, and products that have a high concentration of alcohol, astringents, spices, or lime also may worsen dry skin.
  • Caution patient to use sunscreens with an SPF of at least 15, and protective clothing to prevent photosensitivity reactions. Consult health care professional about sunscreen; some sunscreens may worsen acne. Patients should be taught to minimize exposure to sunlight and sunlamps, and if sunburned to cease tretinoin treatment until fully recovered. Other weather extremes (wind, cold) also may be irritating to skin.

Evaluation/Desired Outcomes

  • Decrease in the number and severity of cysts in severe acne. Therapeutic results are usually seen in 2–3 wk but may require 6 wk for optimal results. Once results are satisfactory, maintain therapy with less frequent applications or other dosage forms.
  • Decreased skin roughness, hyperpigmentation, and wrinkling due to photoaging.

Avita

(ə-vē′tə)
A trademark for the drug tretinoin.

Avita

A proprietary topical retinoid (vitamin A analogue), which is used to treat moderate acne, wrinkles and sun-damaged skin.

Adverse effects
Erythaema, flushing, photosensitivity, irritation, allergic reactions.
References in periodicals archive ?
ReCell is Avita Medical's unique proprietary technology that enables a clinician to rapidly create, at point of care in approximately 30 minutes, Regenerative Epithelial Suspension (RES) using a small sample of the patient's skin.
This patent is an important addition to our intellectual property estate, which further strengthens Avita's position as a leader in skin repair technology, said Adam Kelliher, Chief Executive Officer of Avita Medical Ltd.
Avita Medical says: "It is the only company worldwide to commercialise this type of product.
Avita, has been sussing out Windsor in her role of a snooty air hostess in a Bollywood film based at Heathrow.
John Geisel, a scientist at Avita Medical developing the technology, said: "We need to get these burn wounds closed quickly.
Avita and Frangobras are new poultry companies with tremendous growth potential, Tyson said.
Avita has completed a hat-trick since her return though the longer trip is a concern, while Grattan Lodge is well treated again after a spell in the doldrums.
Customs and Border Protection officer Avita Jaswal track conditions at Los Angeles International Airport's Tom Bradley Terminal.
Retinoic acid, a form of vitamin A that is sold under the brand names Renova, Avita, and Retin-A, can improve fine wrinkles, discoloration, and rough skin from overexposure to sunlight.
Virginia Bottomley, Avita Bhulta (BBC), Ron Middleton, Oliver Howell and Sukhvinder Kaur Stubbs
025% concentration of tretinoin in Avita Cream is attached to high-molecular-weight oligomers that keep it from penetrating transdermally and causing irritation.
9m to support Avita s ongoing US clinical regulatory programme towards FDA Premarket Approval (PMA) and to procure more than 5,000 ReCell devices to establish an inventory so that ReCell can be deployed to help deal with a mass casualty scenario involving burn injuries.